By using this website, requesting services, or making payment to Pragmatic Compliance Inc DBA FDAbasics, you agree to be bound by our Terms & Conditions of Service. Please read them carefully before engaging our services.

FDAbasics Terms & Conditions of Service

Effective Date: February 18, 2026 Last Updated: March 4, 2026 Version: 2.0 

IMPORTANT NOTICE: These Terms & Conditions replace all prior versions. Clients with services commenced prior to February 18, 2026 will continue under their existing terms for the duration of that specific project. These Terms & Conditions apply to all new services, renewals, and projects initiated on or after February 18, 2026. 

1. DEFINITIONS a) “FDAbasics” shall refer to Pragmatic Compliance Inc DBA FDAbasics, its agents and/or representatives. b) “Client” shall include the individual or entity to whom FDAbasics is rendering consulting services, as well as its principals, agents and/or representatives; all principals, agents and/or representatives are deemed to have obtained appropriate authorization from Client prior to entering into this Agreement; it shall be the responsibility of the Client to provide notice and copy(s) of these Terms and Conditions of Service to any principals, agents and/or representatives; c) “Parties” shall refer to FDAbasics and Client collectively; d) “Documentation” shall refer to all information received directly or indirectly from Client, whether in paper or electronic form; e) “Contact Person” shall refer to the individual or entity designated by Client as a contact person in Documentation, and will be the primary contact for all communications from FDAbasics to Client; all communications with Contact Person will be sent via electronic mail (e-mail) unless otherwise provided below; f) “Service Fees” shall refer to fees payable to FDAbasics by Client for the provision of registration, listing, advisory and/or consulting services.
2. AGREEMENT BETWEEN PARTIES AGREEMENT BETWEEN PARTIES AND ACCEPTANCE (A) BINDING AGREEMENT. By (i) paying any invoice issued by FDAbasics, (ii) executing a signature page, proposal, or engagement letter that references these Terms & Conditions, (iii) clicking "I Agree," checking an acceptance box, or any similar action on FDAbasics's website or electronic forms, (iv) submitting Documentation to FDAbasics, or (v) using any services provided by FDAbasics, Client expressly acknowledges, understands, and agrees to be bound by all terms and conditions contained herein. If Client does not agree to these terms, Client must not use FDAbasics's services and must immediately cease all engagement with FDAbasics. (B) AGREEMENT COMPONENTS. These Terms and Conditions of Service, together with: (i) any payment of service fees to FDAbasics; (ii) submission of Documentation; (iii) any U.S. Agent Agreement (if applicable); (iv) any engagement letter, proposal, or quote; and (v) the policies and procedures published on www.FDAbasics.com (which may change from time to time), constitute the entire Agreement between the parties ("Agreement"). (C) PAYMENT AS ACCEPTANCE. Client acknowledges and agrees that payment of any invoice, service fee, or deposit to FDAbasics constitutes Client's full acceptance of and agreement to be bound by these Terms & Conditions, regardless of whether Client has signed a separate agreement or clicked an acceptance button. By remitting payment, Client represents that Client has read, understood, and agrees to these Terms & Conditions. (D) BINDING EFFECT. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. (E) EFFECTIVE DATE AND VERSIONS. These Terms & Conditions are effective as of the date displayed at the top of this document or on www.FDAbasics.com. The version of these Terms & Conditions in effect at the time Client makes payment or accepts services shall govern the relationship between the parties. FDAbasics reserves the right to update these Terms & Conditions at any time by posting the revised version on www.FDAbasics.com. (F) ACKNOWLEDGMENT OF MATERIAL TERMS. Client specifically acknowledges and agrees to the following material terms of this Agreement: (i) all service fees are non-refundable once services commence (Section 5); (ii) FDAbasics's liability is strictly limited as set forth in Section 9; (iii) Client is solely responsible for FDA renewals and updates unless separately contracted (Section 7); (iv) disputes are subject to binding arbitration (Section 16); and (v) FDAbasics does not guarantee FDA approval or acceptance of any submission (Section 3). Client represents that Client has had adequate opportunity to review these terms, consult with legal counsel if desired, and fully understands the rights being waived and obligations being undertaken. (G) EXISTING ClientS. For clients who engaged FDAbasics's services prior to the effective date of these Terms & Conditions, continued use of services, payment of any invoice, or submission of any new project after the effective date constitutes acceptance of these Terms & Conditions for all future services.
3. SCOPE FDAbasics’ scope of services is limited to the services mentioned in the invoice.  Any requests for services beyond the scope originally agreed upon and paid for shall require additional service fees. FDAbasics will provide Client with a quote for such additional services, and Client must approve and pay such fees before FDAbasics commences the additional work. FDAbasics does not guarantee that any submission, registration, or filing will be accepted or approved by the FDA or any government agency. Client acknowledges that government agencies have sole discretion over acceptance and approval decisions, and FDAbasics's services are limited to preparation and submission assistance. FDAbasics does not provide legal advice, and its services do not include: (i) legal representation; (ii) product safety testing; (iii) facility inspections; (iv) defense against FDA enforcement actions; (v) responding to FDA warning letters or Form 483s; or (vi) any services not expressly agreed to in writing. While FDAbasics facilitates electronic filings (e.g., FFRM, ESG), FDAbasics is not responsible for technical failures of government portals or databases.
4. PRIVATE ENTITY & NO GOVERNMENT AFFILIATION The Company is a private, independent consulting firm. We are not a government agency, nor are we affiliated with, endorsed by, or sanctioned by the U.S. Food and Drug Administration (FDA), CBP, or any other regulatory body.
5. PAYMENT OF SERVICE; GOVERNMENT FEES; FEE RETAINERS Unless otherwise expressly stated all service fees to FDAbasics are immediately due and must be paid before any services can be rendered by FDAbasics to Client. Additionally, some registration and listing services require payment of fees to the government agency(ies). Payment of service fees to FDAbasics shall be included with and is in addition to all government fees. The Parties agree that FDAbasics shall not be responsible for submitting or completing any registration, listing, or regulatory filing that requires payment of governmental user fees unless such fees have been paid in full by Client. FDAbasics reserves the right to require a cost deposit, letter of credit, or other form of guarantee from client for the payment of foreseeable government or third party fees, the amount of which shall be set forth in future communications between FDAbasics and Client. All service fees paid to FDAbasics are non-refundable, except as required by law. Once payment is received and services commence, Client acknowledges that FDAbasics has committed resources to Client's matter and no refunds will be provided, even if Client chooses to discontinue services or if the project is not completed due to Client's action or inaction. (a) Wire Transfers: Client is responsible for all bank fees associated with wire transfers. All payments must be sent via the "OUR" instruction (Sender pays all transaction fees) to ensure FDAbasics receives the full invoiced amount. Any shortfall due to bank fees will be billed to Client and may delay service. When paying by wire transfer, Client must include the invoice number and company name/number in the wire transfer reference field to avoid processing delays. Payments without proper references may be delayed until Client identity can be confirmed. (b) Chargebacks: Any Client who initiates a credit card chargeback for services rendered will be liable for the original invoice plus all chargeback fees charged by the payment processor and all legal costs associated with collection. (c) Net Refunds: In the extraordinary event that FDAbasics, at its sole discretion, elects to issue a refund, such refund will be issued net of all transaction fees, including but not limited to credit card processing fees, bank service charges, and wire transfer fees for both incoming and outgoing payments.
6. ADVANCE PAYMENT AND SERVICE COMMENCEMENT. Client acknowledges that FDAbasics operates on an advance payment model. Unless noted otherwise, services will not commence until full payment is received and processed by FDAbasics. By making advance payment, Client authorizes FDAbasics to begin work immediately upon receipt of payment and acknowledges that resources will be committed to Client's matter upon payment. Client further acknowledges that payment of the invoice constitutes acceptance of these Terms & Conditions and the scope of services described in the invoice, quote, or engagement letter. If government agency fees increase after Client has paid FDAbasics but before submission is made, Client agrees to pay the difference in government fees before FDAbasics submits the filing.  If any amounts owed to FDAbasics are not paid when due, FDAbasics may charge interest on the overdue amount at the rate of 1.5% per month (or the maximum rate permitted by law, whichever is lower). Client shall also be responsible for all costs of collection, including reasonable attorney's fees.
7. RELIANCE ON INFORMATION FURNISHED Client shall timely provide FDAbasics with all information, documentation, access credentials, authorizations, and other materials reasonably necessary to perform the Services. Client represents and warrants that all information provided to FDAbasics is complete and accurate to the best of Client’s knowledge. FDAbasics may rely on such information without independent verification. Client shall be solely responsible for ensuring the continued accuracy of information for the duration of the service term. Whenever there is a change to Client’s information, Client’s contact person shall submit written notifications of the change via electronic mail to info@FDAbasics.com; Client shall indemnify and hold FDAbasics harmless from any and all claims asserted and/or liability or losses suffered as a result of Client’s failure to disclose information or any incorrect, incomplete or false statement by Client or its agent, representative or contractor upon which FDAbasics reasonably relied. Client agrees to respond promptly to all requests from FDAbasics for information, documentation, clarifications, or approvals. FDAbasics is not responsible for delays in service delivery or missed deadlines caused by Client's failure to timely provide requested information or approvals. If Client fails to respond to FDAbasics's requests within thirty (30) days, FDAbasics may, at its sole discretion, consider the matter closed and terminate services without refund of fees paid.
8. ONGOING FDA COMPLIANCE AND RENEWALS (A) Client acknowledges that certain FDA registrations, listings, and filings require periodic renewal (including annual or biennial renewal for facility registrations) and that it is Client's sole responsibility to timely renew such registrations unless Client has separately contracted with FDAbasics for renewal services and paid the applicable renewal fees. (B) FDAbasics's services are limited to the specific service period paid for by Client. Unless Client has purchased ongoing maintenance or renewal services, FDAbasics has no obligation to monitor renewal deadlines, send renewal reminders, or maintain Client's registrations beyond the initial service term. (C) Client is solely responsible for updating the FDA and other government agencies of any changes to Client's information, products, processes, ownership, or other material changes after the completion of FDAbasics's services, unless Client has separately engaged FDAbasics for such ongoing services. (D) Client acknowledges that failure to timely renew FDA registrations or update information with the FDA may result in penalties, fines, or loss of market access, and Client agrees to hold FDAbasics harmless from any such consequences. (E) FDA FACILITY REGISTRATION AND PRODUCT LISTING RENEWAL CYCLES. Client acknowledges that different industries have strict mandatory renewal windows: (i) Annual (Oct 1 – Dec 31): Medical Devices, Drug Establishments, and Drug Product Listings. (ii) Biennial (Even Years, Oct 1 – Dec 31): Food Facility Registrations. (iii) Biennial (Anniversary Date): Cosmetic Facility Registrations. (F) ONGOING DUTY TO UPDATE. Client is responsible for ensuring all FDA registration and listing data remains current: (i) Food Facilities: Updates are required within 60 days of any change in facility information. (ii) Drugs & Devices: Updates must be filed immediately for changes in manufacturing operations, ownership, or product specifications. (iii) Cosmetics: Facility and product data must be updated as changes occur to maintain MoCRA compliance.(G) NON-RESPONSIVENESS & NON-PAYMENT. FDAbasics is not an automated service. If FDAbasics contacts Client to confirm data for a mandatory renewal or update and Client fails to provide written confirmation, updated data, or payment by the invoice due date, FDAbasics will not process the filing.(H)CONSEQUENCES OF INACTION. The FDA automatically cancels registrations that are not renewed within the statutory window. FDAbasics shall be held harmless for any cancellation, import detention, or loss of market access resulting from Client's failure to respond or pay for renewal services.
9. DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY (A) DISCLAIMER OF WARRANTIES. TO THE FULLEST EXTENT PERMITTED BY LAW, FDAbasics'S SERVICES ARE PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO: (i) No Warranty of Regulatory Outcomes: FDAbasics makes no warranty, guarantee, or representation that any FDA submission will result in approval, clearance, acceptance, or favorable regulatory action. Regulatory decisions are made solely by the FDA, and outcomes are beyond FDAbasics's control. (ii) No Warranty of Accuracy: While FDAbasics strives to provide accurate and current regulatory guidance, the regulatory landscape is subject to frequent changes. FDAbasics does not warrant that its advice, interpretations, or submissions will align with future FDA guidance, policy shifts, or enforcement priorities. (iii) No Warranty of Merchantability or Fitness: FDAbasics disclaims all implied warranties of merchantability, fitness for a particular purpose, title, and non-infringement. (iv) Third-Party Systems: FDAbasics is not responsible for the functionality, availability, or accuracy of government portals, databases, or systems operated by the FDA, CBP, or other agencies. Technical failures, downtime, or data loss on such systems are beyond FDAbasics's control. (v) No Guarantee of Market Access: Completing FDA registration, listing, or obtaining a U.S. Agent does not guarantee that Client's products will be permitted entry into U.S. commerce or that Client will avoid FDA enforcement actions, warning letters, or import detentions. Client ACKNOWLEDGES THAT IT IS ENGAGING FDAbasics FOR ADMINISTRATIVE AND CONSULTATIVE SUPPORT ONLY, AND THAT FDAbasics MAKES NO GUARANTEES REGARDING BUSINESS OUTCOMES, REGULATORY COMPLIANCE, OR LEGAL PROTECTION. (B) LIMITATION OF LIABILITY - REGISTRATION AND LISTING SERVICES. THE PARTIES AGREE THAT IF THE Client SUFFERS ANY LOSS, DAMAGE, PENALTY, FINE, ASSESSMENT OR OTHER PECUNIARY INJURY (EACH AND/OR ALL OF THE FOREGOING REFERRED TO AS "LOSS") CAUSED BY, ARISING FROM, OR RELATED TO FDAbasics'S REGISTRATION AND LISTING SERVICES, FDAbasics'S LIABILITY FOR SUCH LOSS SHALL BE LIMITED TO FIFTY-DOLLARS ($50.00) PER REGISTRATION OR LISTING. (C) LIMITATION OF LIABILITY - OTHER SERVICES. FDAbasics'S LIABILITY FOR CLAIMS ARISING FROM SERVICES OTHER THAN REGISTRATION AND/OR LISTING SHALL BE LIMITED TO TEN PERCENT (10%) OF THE SERVICE FEES PAID TO FDAbasics FOR THE SPECIFIC SERVICE THAT RESULTED IN THE LOSS. (D) NO CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL FDAbasics BE LIABLE OR RESPONSIBLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, REMOTE, SPECULATIVE, STATUTORY OR PUNITIVE DAMAGES, EVEN IF IT HAS BEEN PUT ON NOTICE OF THE POSSIBILITY OF SUCH DAMAGES, OR FOR THE ACTS OF THIRD PARTIES. IN NO EVENT SHALL FDAbasics BE LIABLE OR RESPONSIBLE FOR THE PAYMENT OF ANY FEES OWED TO ANY GOVERNMENT AGENCY BY Client; ANY CLAIMS FROM A GOVERNMENT AGENCY RESULTING FROM UNPAID FEES; NOR FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, REMOTE, SPECULATIVE, STATUTORY OR PUNITIVE DAMAGES THAT MAY RESULT FROM Client'S FAILURE TO PAY ANY GOVERNMENT FEES. (E) FORCE MAJEURE. FDAbasics SHALL NOT BE LIABLE FOR LOSS, DAMAGE, DELAY OR MONETARY LOSSES OF ANY TYPE CAUSED BY: ACTS OF GOD; PUBLIC AUTHORITIES ACTING WITH ACTUAL OR APPARENT AUTHORITY; WEATHER; MECHANICAL FAILURES; CIVIL COMMOTIONS; PUBLIC ENEMIES; HAZARDS INCIDENT TO A STATE OF WAR; ACTS OF TERRORISM; FIRE; FLOOD; EARTHQUAKE; EPIDEMIC; PANDEMIC; QUARANTINE RESTRICTIONS; LABOR DISPUTES; STRIKES; GOVERNMENT ORDERS OR RESTRICTIONS; FAILURE OR DELAY OF THIRD-PARTY SERVICE PROVIDERS; INTERNET OR TELECOMMUNICATIONS FAILURES; CYBER ATTACKS; AND ACTS, DEFAULTS OR OMISSIONS OF THE Client OR CONTACT PERSON; Client'S CARELESSNESS OR NEGLIGENCE; AND FOR Client'S FAILURE TO OBSERVE THESE TERMS AND CONDITIONS. (F) EXCEPTIONS TO LIMITATION OF LIABILITY. Notwithstanding the limitations set forth in subsections (B), (C), and (D) above, the limitation of liability shall not apply to: (i) Claims arising from FDAbasics's gross negligence or willful misconduct; (ii) Claims arising from FDAbasics's breach of confidentiality obligations under Section 17; (iii) Claims arising from FDAbasics's fraud, intentional misrepresentation, or criminal conduct; (iv) Data breaches caused by FDAbasics's failure to implement the security measures described in Section 17; (v) Claims for which limitation of liability is prohibited by applicable law; (vi) Claims covered by FDAbasics's insurance policies, in which case recovery may be sought up to the limits of applicable insurance coverage (subject to policy terms, conditions, and exclusions). (G) INSURANCE COORDINATION. Where FDAbasics maintains insurance coverage applicable to a claim, Client may pursue recovery under such insurance policies up to the policy limits, subject to the insurance carrier's determination of coverage. This provision does not waive any other limitation of liability set forth in this Agreement for amounts exceeding insurance coverage or for claims not covered by insurance.
10. MUTUAL INDEMNIFICATION (A) Client INDEMNIFICATION OF FDAbasics. Client agrees to indemnify, defend, and hold FDAbasics harmless from any claims and/or liability, fines, penalties and/or attorneys' fees arising from any conduct of the Client or its Contact Person, agents, assigns and representatives, including but not limited to: (i) The inaccuracy of information on Documentation provided to FDAbasics which violates any Federal, State and/or other laws; (ii) Failure to communicate with FDAbasics and/or respond to notices and requests from FDAbasics; (iii) Misunderstandings and misinterpretations of information received from FDAbasics or obtained on www.fdabasics.com; (iv) Nonpayment of fees to government agencies; (v) Client's manufacturing, marketing, distribution, or sale of products; (vi) Product safety, efficacy, labeling, or regulatory compliance issues related to Client's products; (vii) Intellectual property infringement by Client's products; (viii) Claims arising from Client's failure to renew FDA registrations or update the FDA as required. (B) FDAbasics INDEMNIFICATION OF Client. FDAbasics agrees to indemnify, defend, and hold Client harmless from third-party claims arising solely from: (i) FDAbasics's gross negligence or willful misconduct in performing services under this Agreement; (ii) FDAbasics's breach of its confidentiality obligations under Section 12; (iii) Data breaches caused solely by FDAbasics's failure to maintain the commercially reasonable security measures described in Section 12; (iv) FDAbasics's violation of applicable laws in performing services, where such violation does not result from Client's instructions or information. (C) INDEMNIFICATION PROCEDURES. (i) The indemnified party must promptly notify the indemnifying party in writing of any claim for which indemnification is sought. (ii) The indemnifying party shall have the right to control the defense of any claim with counsel of its choice, provided such counsel is reasonably acceptable to the indemnified party. (iii) The indemnified party may participate in the defense at its own expense with counsel of its choice. (iv) No settlement may be entered into without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld. (v) Failure to provide prompt notice may relieve the indemnifying party of its obligations to the extent it is prejudiced by such failure. (D) INSURANCE AS FIRST RECOURSE. To the extent either party maintains insurance covering a claim, the indemnified party agrees to seek recovery first from applicable insurance before seeking indemnification from the indemnifying party. (E) SURVIVAL. The indemnification obligations set forth in this Section shall survive termination or expiration of this Agreement.
11. IMPORTATION & DETENTION RISKS FDAbasics is not liable for costs associated with U.S. Customs and Border Protection (CBP) actions, including storage fees, demurrage, or the placement of Client on an FDA Import Alert.
12. TERMINATION This Agreement will automatically terminate upon completion or upon expiration of the service term for which Client has remitted payment to FDAbasics. The Parties agree that FDAbasics may terminate this Agreement at any time for non-payment, fraud, or failure to observe these terms and conditions. FDAbasics will provide written notice of termination to Contact Person via electronic mail (e-mail), at least ten (10) days before the termination date, whenever practicable, or within fifteen (15) days of the termination date, in all other instances. If Client wishes to cancel services after payment but before FDAbasics has commenced work, Client may request cancellation within five (5) business days of payment for a refund minus a $250 administrative fee. After services have commenced, no refunds will be provided.
13. CONFIDENTIALITY AND DATA PROTECTION (A) CONFIDENTIALITY. With the exception of communications with government agencies, or for purposes of collection, FDAbasics shall not disclose information designated as confidential by Client and will treat said information with the same care and confidentiality it treats its own confidential information. FDAbasics is an independent advisory and consulting company, not a law firm. Communications between Client and FDAbasics are not subject to attorney-client privilege. (B) DATA PROTECTION ROLES. For purposes of applicable data protection laws, including the California Consumer Privacy Act ("CCPA"), California Privacy Rights Act ("CPRA"), and the European Union General Data Protection Regulation ("GDPR"), the parties acknowledge that: (i) Client is the data controller or business with respect to any personal data or personal information of third parties (including Client's employees, customers, or contacts) that Client provides to FDAbasics; (ii) FDAbasics is a service provider (under CCPA/CPRA) or data processor (under GDPR) acting on behalf of Client; (iii) FDAbasics will process personal data only for the purpose of providing the services described in this Agreement and in accordance with Client's documented instructions. (C) PERSONAL INFORMATION COLLECTED. In connection with providing services, FDAbasics may collect and process the following categories of personal information from or on behalf of Client: names, email addresses, phone numbers, business addresses, job titles, company affiliations, product information, facility information, government identification numbers, IP Addresses and other information necessary to provide FDA consulting services. (D) DATA SECURITY. FDAbasics will maintain reasonable administrative, technical, and physical safeguards to protect Client's Documentation and information from unauthorized access, use, or disclosure, including but not limited to encryption, access controls, and secure data storage. (E) THIRD-PARTY SERVICE PROVIDERS. Client acknowledges that FDAbasics may store and process data using third-party service providers (sub-processors), and Client consents to such use provided such third parties are bound by confidentiality and data protection obligations substantially similar to those in this Agreement. FDAbasics will maintain a list of sub-processors available upon request. (F) INTERNATIONAL DATA TRANSFERS. If Client is located in the European Economic Area, United Kingdom, or Switzerland, and FDAbasics processes personal data on Client's behalf, the parties agree that data transfers to the United States shall be governed by the Standard Contractual Clauses approved by the European Commission, which are incorporated by reference and available at [insert URL or "upon request"]. (G) DATA SUBJECT RIGHTS. FDAbasics will reasonably assist Client in responding to requests from data subjects (individuals) exercising their rights under applicable data protection laws, including rights of access, rectification, erasure, data portability, restriction of processing, and objection. Client is responsible for responding to such requests, and FDAbasics will cooperate upon Client's written request and at Client's expense. (H) DATA BREACH NOTIFICATION. FDAbasics will notify Client within forty-eight (48) hours of becoming aware of any unauthorized access, disclosure, or breach of Client's personal data. FDAbasics will reasonably cooperate with Client in investigating and remediating any such breach. (I) DATA RETENTION AND DELETION. FDAbasics will retain Client data only for the duration necessary to provide services and comply with legal obligations. Upon termination or upon Client's written request, FDAbasics will delete or return all personal data to Client within thirty (30) days, except where retention is required by law. (J) NO SALE OF PERSONAL INFORMATION. FDAbasics does not sell or share personal information as defined by the CCPA/CPRA. (K) Client RESPONSIBILITIES. Client represents and warrants that: (i) it has obtained all necessary rights, consents, and authorizations to provide personal data to FDAbasics; (ii) it has provided all required privacy notices to data subjects; and (iii) its provision of personal data to FDAbasics complies with all applicable data protection laws. Client agrees to indemnify FDAbasics for any violations of data protection laws arising from Client's failure to obtain necessary consents or provide required notices. (L) AUDITS. Upon reasonable written notice and no more than once per year, Client may audit FDAbasics's compliance with this Section 12, or Client may accept FDAbasics's SOC 2 or ISO 27001 certification (if available) in lieu of an audit. (M) PRIVACY CONTACT. For privacy-related inquiries, contact FDAbasics at legal@fdabasics.com. (N) DATA BREACH INDEMNIFICATION. If a data breach occurs that is caused solely by FDAbasics's failure to implement the commercially reasonable security measures described in subsection (D), FDAbasics agrees to: (i) Notify Client within forty-eight (48) hours of becoming aware of the breach; (ii) Cooperate with Client in investigating and remediating the breach; (iii) Bear reasonable costs of breach notification, credit monitoring, and remediation services to the extent such breach was caused by FDAbasics's negligence and to the extent covered by FDAbasics's cyber liability insurance; and (iv) Indemnify Client for third-party claims arising solely from FDAbasics's negligent failure to maintain required security measures, subject to the limitations set forth in Section 10(F). (O) INSURANCE FOR DATA BREACHES. FDAbasics maintains cyber liability insurance that includes coverage for data breach response costs, breach notification, credit monitoring services, and third-party liability arising from data security incidents. Client acknowledges that FDAbasics's liability for data breach incidents shall be limited to the extent of insurance coverage, subject to policy terms, conditions, and exclusions. (P) Client'S BREACH NOTIFICATION OBLIGATIONS. Client acknowledges that Client (not FDAbasics) is the data controller/business under applicable data protection laws and is responsible for determining whether a breach requires notification to regulators or data subjects. FDAbasics will reasonably cooperate with Client in fulfilling these obligations. (Q) Marketing communications: By providing contact information, you agree that FDAbasics may contact you regarding service updates or regulatory news; you may opt-out of these communications at any time. (R) No mobile information will be shared with third parties/affiliates for marketing/promotional purposes. All OPT-IN requests include text messaging originator opt-in data and consent; this information will not be shared with third parties.
14. ASSIGNMENT Neither party may assign this Agreement or any rights or obligations hereunder without the prior written consent of the other party, except that FDAbasics may assign this Agreement to any affiliate, subsidiary, or successor entity, or in connection with any merger, acquisition, or sale of all or substantially all of its assets. Any attempted assignment in violation of this Section shall be null and void. Subject to the foregoing, this Agreement shall bind and inure to the benefit of the parties and their respective successors and permitted assigns. (a) ELECTRONIC SIGNATURES AND COMMUNICATIONS (A) Client consents to the use of electronic signatures, electronic records, and electronic delivery of notices, agreements, invoices, and all other communications pursuant to this Agreement. (B) Client agrees that any electronic signature (including clicking "I Agree," typing Client's name, or checking an acceptance box) has the same legal effect as a handwritten signature and that such electronic acceptance is valid, enforceable, and admissible in any legal proceeding. (C) Client agrees to receive all communications from FDAbasics electronically via email at the email address provided by Client. Client is responsible for ensuring the email address on file is current and for monitoring such email account. (D) Client may withdraw consent to electronic communications by providing written notice to legal@fdabasics.com, but such withdrawal shall constitute termination of services and Client will not be entitled to any refund of fees paid.
15. NOTICES All notices, requests, demands, and other communications required or permitted under this Agreement shall be in writing and shall be deemed to have been duly given: (a) upon personal delivery; (b) one (1) business day after being sent by reputable overnight courier service; (c) three (3) business days after being sent by certified or registered mail, return receipt requested; or (d) upon transmission if sent by electronic mail with confirmation of receipt. Notices to FDAbasics shall be sent to legal@fdabasics.com or such other address as FDAbasics may designate in writing. Notices to Client shall be sent to the Contact Person at the email address provided in the Documentation or such other address as Client may designate in writing.
16. AMENDMENTS No amendment, modification, or waiver of any provision of this Agreement shall be effective unless in writing and signed by both parties. FDAbasics may update its policies and procedures published on www.FDAbasics.com from time to time, and continued use of FDAbasics services after such updates constitutes acceptance of such changes.
17. GOVERNING LAW; VENUE AND CONSENT TO JURISDICTION This Agreement shall be governed by and construed in accordance with the laws of the state of Florida (without giving effect to its choice of law or conflict of law provisions). The Parties hereto irrevocably and unconditionally submit to the jurisdiction of the state and federal courts located in Broward County and irrevocably agree that all actions or proceedings arising out of or relating to this agreement or the transactions contemplated herein shall be litigated exclusively in such. The parties further agree that an action to enforce judgment may be instituted in any jurisdiction.
18. ARBITRATION Any controversy or claim arising out of or relating to these Terms and Conditions of Service and/or the relationship of the parties, shall be conclusively resolved through binding arbitration under the Commercial Arbitration Rules of the American Arbitration Association. Judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof. Each party shall bear its own costs and attorney fees, unless the arbitration award specifically provides otherwise. The seat, or legal place, of arbitration shall be Broward County, Florida, USA. The arbitration shall be in English.
19. ATTORNEY’S FEES In the event of a judicial or administrative proceeding or action with respect to the interpretation or enforcement of this Agreement, the prevailing party shall be entitled to recover reasonable costs and expenses including, without limitation, reasonable attorneys’ fees and expenses, whether at the investigative, pretrial, trial or appellate level. The prevailing party shall be determined by the court based upon an assessment of which party’s major arguments or position prevailed.
20. SEVERABILITY If any covenant or other provision of these Terms and Conditions of Service is deemed to be invalid, illegal or incapable of being enforced, by reason of any rule, law or public policy, all other covenants and provisions of this document shall nevertheless remain in full force and effect and no covenant or provision shall be deemed dependent on any other covenant or provision unless so expressed herein.
21. WAIVERS The failure or delay of any party hereto in exercising any right granted it hereunder shall not constitute a waiver of any such right and any single or partial exercise of any particular right by such party shall not exhaust the same or constitute a waiver of any other right provided herein.
22. APPLICATION This Agreement shall not be construed more strictly against one party than against the other merely by virtue of the fact that it may have been prepared primarily by counsel for one of the parties, it being recognized that all parties have had the opportunity to review this Agreement, seek legal counsel regarding its provisions and all parties understand the terms and conditions contained herein.
23. ENTIRE AGREEMENT This Agreement constitutes the entire agreement between the Parties with respect to the matters set forth herein, and supersedes all prior understandings between the Parties with respect to matters relating to the services to be performed by FDAbasics.
24. INTELLECTUAL PROPERTY All work product, documents, forms, and submissions prepared by FDAbasics for Client shall become the property of Client upon receipt of full payment. However, FDAbasics retains ownership of its methodologies, templates, processes, and any pre-existing intellectual property. Client grants FDAbasics permission to use Client's company name and a general description of services provided as a reference, unless Client objects in writing. Users and Clients are prohibited from copying, downloading, or storing any website content or proprietary information without express written authorization.
25. INSURANCE FDAbasics maintains Commercial General Liability, Professional Liability, and Cyber Liability insurance. Certificates available upon request at legal@fdabasics.com. Maintenance of insurance does not waive any limitation of liability in this Agreement.
26. U.S. AGENT SERVICES If appointed as a U.S. Agent, Client acknowledges (1) FDAbasics's role is a communication link per 21 CFR § 1.227. (2) FDAbasics may withdraw as U.S. Agent if Client fails to pay the annual U.S. Agent fee or fails to respond to FDA in a timely manner. Client acknowledges that removal of U.S. Agent information may cause the FDA to cancel the facility registration. (3) Client agrees to indemnify FDAbasics for any costs incurred due to its status as U.S. Agent. (4) For U.S. Agent representation services, Client acknowledges that FDAbasics will receive communications from the FDA on Client's behalf and will forward such communications to Client. Client must respond promptly to any FDA communications. (5) FDAbasics's role as U.S. Agent is administrative only and does not include legal representation or defense of Client in FDA enforcement matters. (6) U.S. Agent services terminate upon expiration of the service term or upon termination of this Agreement, and Client must appoint a new U.S. Agent if required by FDA regulations. (7) Product Liability Waiver Client agrees that FDAbasics has no involvement in or specific knowledge of Client’s products and will not hold FDAbasics liable for any damages arising from the performance or safety of those products. (8) Labeling & Distributor Prohibitions Client shall not use FDAbasics’ name on any product labels, packaging, or marketing materials, nor represent FDAbasics as a distributor without prior written consent. (9) FSVP Agent Exclusion This agreement is for U.S. Agent services only and specifically excludes FSVP (Foreign Supplier Verification Program) agent services or representation for adverse event reporting.4. Non-Refundable FeesAll fees paid for U.S. Agent services are non-refundable and cover only the specific services selected at the time of payment. (10) Facility-Specific Limitation Each U.S. Agent appointment is valid only for the specific facility name and address provided; multiple facility locations require separate registrations and fees. (11) Scope of Services U.S. Agent fees do not include any other consulting or regulatory filings (such as 510k, ANDA, IND, or controlled correspondence) unless a separate agreement is signed. (12) Warranty of Accuracy Client warrants that all information provided is truthful and accurate and acknowledges it is the Client’s sole responsibility to provide updates regarding any changes to facility information. (13) Unauthorized Post-Expiration Use If the Client continues to use FDAbasics as its U.S. Agent beyond the validity period without paying for a renewal, FDAbasics may cancel the registration and the Client remains liable for fees at the current invoiced rate.
27. LABELING REVIEW SERVICES If the invoice includes "Labeling Compliance Review," the fee covers the initial report plus two rounds of follow-up reviews; subsequent revisions incur additional charges. Additionally, Client acknowledges: (i) The labeling review includes verification of mandatory statements, Nutrition/Supplement Facts (for food), Drug Facts (for OTC drugs), or Cosmetic ingredient lists, as well as health, nutrient, or product claims and general formatting for the specific items mentioned on the invoice. (ii) FDAbasics does not offer legal advice and is not responsible for consequential damages arising from any product rejection due to improper labeling or ingredients. The FDA does not review or approve the labels. (iii) FDAbasics shall review the labels and send comments back to the Client. Client must make corrections as per recommendations and send them back for further review. FDAbasics will not edit or modify the labels. (iv) The labeling review does not include other services, such as review of promotional brochures or website review. (v) FDAbasics shall provide recommendations on the FDA's required font size and formatting; however, it is not possible to measure the font size or bar line size. (vi) Ingredient review, ingredient safety, and toxicity assessment are not covered within the scope of the labeling review. (vii) The labeling review is limited to the pack/products mentioned on the invoice. (viii) Labeling review and compliance are subjective in nature. FDAbasics's recommendations are based on knowledge and experience, but do not guarantee acceptance by the FDA. (ix) Upon receipt of updated labels, FDAbasics shall verify corrections; however, FDAbasics will not edit or modify labels directly. (x) The standard timeline for review is ten (10) business days, subject to the Client's response speed. Review begins only upon receipt of both the labeling fee and designs in PDF format. (xi) Ingredient safety, toxicity assessments, promotional brochures, and website reviews are strictly excluded from this scope. (xii) FDAbasics provides recommendations on required font and formatting, but cannot physically measure final print sizes. (xii) FDAbasics is a private consulting firm not associated with the FDA; our services do not constitute legal advice or a guarantee of FDA acceptance, and we are not responsible for consequential damages arising from product rejection. (xiv) For cosmetic label reviews, FDAbasics is not responsible for identifying common names for cosmetic ingredients. (xv) For OTC Drug Labeling Review: The scope of service specifically includes verification of mandatory statements, Drug Facts panel compliance (per 21 CFR 201.66), and content review against applicable FDA Monographs. Client shall hold harmless and indemnify FDAbasics against any claims related to the product’s marketing, labeling, or electronic Drug Listing with the FDA. All OTC labeling review fees are non-refundable, and the standard 10-business-day timeline commences only upon receipt of the full fee and final label designs in PDF format.
28. DUNS NUMBER ASSISTANCE If Client engages FDAbasics for DUNS number application assistance, Client acknowledges: (i) The Client acknowledges that a DUNS number is location-specific and must correspond to the exact physical address of the facility. A unique DUNS number is required for each individual site engaged in the manufacturing, packing, processing, or holding of products regulated by the FDA, including food, drugs, and medical devices. For cosmetic facilities, a DUNS is currently requested as optional under MoCRA. If the Client maintains separate addresses for corporate offices and operational facilities, a distinct DUNS number must be obtained for each location.  (ii) The DUNS number assignment timeline typically takes 10 business days but depends on D&B and cannot be guaranteed by FDAbasics. (iii) Client must provide accurate information; if application is rejected due to incorrect data provided by Client, a re-submission fee applies (iv) While FDAbasics facilitates the application process, the Client acknowledges that the ultimate issuance and assignment of a DUNS number are at the sole discretion of Dun & Bradstreet (D&B). FDAbasics maintains no authority over D&B’s internal approval protocols, timelines, or final determinations. (v) FDABasics is a private consulting firm and not associated with D&B. (vi) Client authorizes FDAbasics and their associates to submit the DUNS number application on behalf of your company (vii) Client affirms they are a duly authorized representative of the company authorized to act on behalf of the company to request the a new DUNS number or update to an existing DUNS number. (viii) The fee for DUNS number assistance is non-refundable. This policy remains in effect even if it is subsequently determined that the facility already possesses an active DUNS number at the time of application or thereafter.
29. Cosmetic Facility Registration MoCRA: For facility registration services required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): Client acknowledges, (A) FEI & PORTAL. FDAbasics will assist in obtaining an FEI number and submitting registration via the Cosmetics Direct portal; however, Client understands that FEI assignment timelines are determined solely by the FDA and are outside of FDAbasics’ control. (B) SERVICE FEES & REFUNDS. As of 2026, the FDA does not charge a user fee for cosmetic registration; fees paid to FDAbasics are service charges for professional consultation and are non-refundable unless FDAbasics fails to perform the submission. Delays caused by the Client’s failure to provide requested information in a timely manner shall not be deemed a service failure. (C) ACCURACY & ELIGIBILITY. Client certifies they are not a provider of FDA compliance services and warrants that all information provided is truthful and accurate. (D) RENEWAL & SAFETY. Facilities must renew registration biennially (every two years). Unless separately contracted, FDAbasics’ role does not include mandatory adverse event reporting or the maintenance of safety substantiation records, for which the Client retains sole responsibility.
30. MOCRA COSMETIC PRODUCT LISTING SERVICES For cosmetic product listings required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): (A) Client authorizes FDAbasics to handle the submission process as required by the FDA for the information provided by the client.  FDAbasics is responsible for making sure technical validation, such as SPL validation rules, are met for the submission.(B) RENEWAL OF LISTINGS SUBMITTED BY OTHER AGENTS. If a product listing was originally submitted by a different agent, consultant, employee, or third-party, FDAbasics will renew the listing "as is" and will not be responsible for the content or accuracy of that product listing. (C) Client RESPONSIBILITY FOR ACCURACY. Client retains full responsibility for product composition, ingredient safety, labeling accuracy, intellectual property clearance, and regulatory compliance. FDAbasics' role is limited to technical submission and SPL (Structured Product Labeling) validation. (D) ABBREVIATED ANNUAL RENEWALS. Section 607(c)(5)(B) of the FD&C Act requires registrants to submit an abbreviated annual renewal for cosmetic products that have no changes. If there have been no changes to Client's existing products, FDAbasics can submit an abbreviated renewal on Client's behalf upon instruction and payment. (E) Client acknowledges that all information provided for MoCRA submissions must be truthful and accurate. (F) While FDAbasics facilitates the process, the timeline for FEI (FDA Establishment Identifier) assignment is determined solely by the FDA and is outside of FDAbasics’ control. Consequently, any delays resulting from the FDA’s response time or the Client’s failure to provide requested information in a timely manner shall not be deemed a service failure by FDAbasics. (G) All service fees paid are non-refundable unless FDAbasics fails to perform the requested technical submission; no refunds will be issued for applications delayed or rejected due to external FDA processing or incomplete Client data.
31. MEDICAL DEVICE REGISTRATION SERVICES For medical device establishment registration and listing services: (A) FURLS ACCOUNT CREATION. FDAbasics will assist in creating a FURLS (FDA Unified Registration and Listing System) account and submitting device establishment registration. (B) DEVICE CLASSIFICATION. Client is solely responsible for correctly classifying its medical devices. FDAbasics may provide guidance on device classification, but Client retains ultimate responsibility for classification accuracy. (C) NO FDA CERTIFICATE. The FDA does not issue certificates for device establishment registration. Any certificate provided by FDAbasics is for business facilitation and reference purposes only and is not an FDA-issued document. (D) PREMARKET NOTIFICATION (510K) TIMELINES. If applicable, FDA review timelines for 510(k) submissions are typically 4-5 business days after payment is received by the FDA, but FDAbasics does not control or guarantee FDA processing times. (E) U.S. AGENT LIMITATIONS. When FDAbasics serves as U.S. Agent for medical device establishments, the role does not include adverse event reporting, complaint handling, or submission of 510(k) premarket notifications unless separately contracted.  (F) The fee mentioned in the invoice does not include the FDA Annual Establishment Registration Fee or any other applicable fee.  After you make the payment to the FDA for the Annual Establishment Registration Fee, it will take 4 to 5 business days to obtain a PCN number from the FDA which is required for the completion of your registration. (G)The FDA requires medical devices to be renewed each year during the renewal period (Oct-Dec). If you do not renew during this time, the FDA will cancel your registration. (H) If the product is listed under the FDA’s enforcement policy, it remains your responsibility to comply with the requirements that are mentioned in such the enforcement policy.
32. Labeler Code Request: If the invoice includes Labeler Code Requests, Client acknowledges, (1) Processing Timelines: The standard processing time for an initial NDC Labeler Code Request is approximately 10 business days. Upon assignment, the FDA will send a notification to the contact email address provided in the submission. (2) Truthful Information & Legal Penalties: Under 18 U.S.C. § 1001, submitting materially false, fictitious, or fraudulent statements to the U.S. Government is a federal offense subject to criminal penalties. Providing inaccurate data may result in the immediate inactivation of the labeler code and the delisting of all associated drug products. (3) U.S. Agent Representation: Pursuant to FDA regulations, foreign facilities must appoint a U.S. Agent. A separate U.S. Agent fee will be applied to each unique labeler code request (company). (4) Refund Policy: Fees are service-based and are strictly non-refundable once FDAbasics has commenced work on the project or submission files. (5) Company Identity: FDAbasics is a private regulatory consultancy. We are not affiliated with or endorsed by the U.S. Food and Drug Administration (FDA). (6) ESG Authorization: To facilitate electronic submissions through the FDA Electronic Submission Gateway (ESG), the Client must provide an Authorization Letter (Letter of Non-Repudiation). FDAbasics will provide the required template, which must be printed on company letterhead and signed by an authorized representative. (7) No Legal Advice: Any guidance or information provided by FDAbasics regarding FDA compliance is for general informational purposes only. Our responses do not constitute legal advice or a legal opinion.
33. DRUG ESTABLISHMENT REGISTRATION If the invoice contains Drug Establishment Registration services, Client Acknowledges (1) Scope: Services are limited to initial Drug Establishment Registration and the assignment of an FDA Establishment Identifier (FEI) as specified in the invoice. (2) FEI Assignment & Timelines: Registration typically processes within 3–5 business days; however, the formal assignment of a permanent FEI number by the FDA can take up to 60 business days. This timeline is subject to FDA capacity and does not affect the facility's ability to conduct business if the initial registration is successful. (3) Annual Renewal: Drug establishment registrations must be renewed annually between October 1st and December 31st. Failure to renew will result in registration cancellation. (4) OMUFA Fees: OTC drug manufacturers are responsible for the annual Over-the-Counter Monograph Drug User Fee (OMUFA). Client acknowledges this is an FDA-mandated fee paid directly to the government and is separate from FDAbasics' service fees. (5) cGMP Responsibility: The Manufacturer/Packer is solely responsible for compliance with Current Good Manufacturing Practices (cGMP) and all quality control standards. (6) Foreign Establishments & U.S. Agent: A separate U.S. Agent fee applies to each individual foreign establishment. This representation is required by 21 CFR 207 to maintain valid registration for non-domestic entities. (7) Private Label Distributors (PLD): Pursuant to FDA regulations, a PLD is not required to submit a drug establishment registration; this requirement applies only to firms engaged in the manufacturing, repacking, or relabeling of the drug. (8) Registration Verification: The FDA does not issue certificates. Registration status can be verified via the FDA Drug Establishments Current Registration Site (DECRS). (9) Truthful Information: Client is solely responsible for ensuring all information provided is truthful, accurate, and complete. Materially false statements are subject to criminal penalties under 18 U.S.C. § 1001.(10) Authorization Letter: Client must provide an executed Authorization Letter (Letter of Non-Repudiation) on company letterhead to facilitate electronic submissions through the FDA Gateway. (11) Private Entity Status: FDAbasics is a private company and is NOT associated with or endorsed by the U.S. Food and Drug Administration. (12) No Legal Advice: Guidance provided is for informational purposes only and does not constitute a legal opinion. (13) Refund Policy: Fees are non-refundable once the project has been initiated or the initial review of Client-provided data has begun.
34. Drug Listing Services: If the invoices is for drug listing services, Client acknowledges (1) Scope: Services include Drug Product Listing (SPL submission) as specified in the invoice. (2) Labeler Code & NDC Assignment: Labeler codes are assigned by the FDA; FDAbasics facilitates the request but does not control the assignment. Once the listing is complete, the NDC typically appears in the FDA’s NDC Directory within 2–3 business days. (3) New Product Definition: Any change to active or inactive ingredients, product name, fragrance, dosage form, or route of administration constitutes a "New Product." Such modifications require a new drug product listing and are subject to separate service fees. (4) Pack Sizes: There is no additional fee for adding multiple pack sizes (configurations) to a single product listing, provided all sizes are submitted during the initial FDA filing. (5) Annual Listing Certification: In addition to establishment registration, the FDA requires that all drug listings be certified annually. Between October 1st and December 31st, the Client must certify that no changes have been made to their listings or submit necessary updates. Failure to perform this annual certification will result in the product being inactivated and removed from the FDA’s NDC Directory. FDAbasics is not responsible for listings that lapse due to a Client’s failure to request or pay for certification services. (6) Subjectivity & Liability: Labeling compliance is subjective. FDAbasics provides recommendations based on professional experience which do not constitute a guarantee of FDA acceptance. FDAbasics is not liable for consequential damages resulting from product rejection due to labeling or formulation issues. (7) Listing Maintenance: It is the Client’s responsibility to submit a delisting request for any product no longer in commercial distribution. (8) Truthful Information: Client is solely responsible for ensuring all information provided is truthful, accurate, and complete. Materially false statements are subject to criminal penalties under 18 U.S.C. § 1001. (9) Authorization Letter: Client must provide an executed Authorization Letter (Letter of Non-Repudiation) on company letterhead to facilitate electronic submissions through the FDA Gateway. (10) Private Entity Status: Pragmatic Compliance Inc (DBA FDAbasics) is a private company and is NOT associated with or endorsed by the U.S. Food and Drug Administration. (11) No Legal Advice: Guidance provided is for informational purposes only and does not constitute a legal opinion. (12) Refund Policy: Fees are non-refundable once the project has been initiated or the initial review of Client-provided data has begun.
35. GDUFA Self-Identification: If services include GFUDA self identifcation services, Client acknowledges, (1) Scope of Service: FDAbasics will provide technical assistance in the electronic submission of the GDUFA Self-Identification Structured Product Labeling (SPL) for the facility. This service is limited to the technical filing process and does not include a legal determination by FDAbasics regarding the Client’s statutory obligation to self-identify. (2) Annual Reporting Requirement: Client acknowledges that GDUFA Self-Identification is a mandatory annual requirement. The reporting period occurs between May 1st and May 31st each year. Failure to re-identify annually may result in the facility being excluded from the FDA’s approved list for generic drug participation, and FDAbasics shall not be held liable for any such exclusion. (3) User Fee Liability: The Client is solely responsible for identifying and paying any applicable GDUFA Facility Fees (e.g., FDF, API, or CMO fees) to the FDA. Annual facility fees are due on the first business day on or after October 1st of each year. FDA typically publishes the fee rates in August and payment must be received by the October 1st deadline to remain in good standing. Fees paid to FDAbasics are professional service charges for submission assistance only and do not include or cover FDA-mandated user fees. (4) Arrears List & Business Impact: Client understands that failure to pay GDUFA facility fees or inaccurate self-identification may result in the facility being placed on the FDA GDUFA Arrears List. Placement on this list may result in the FDA's refusal to receive Abbreviated New Drug Applications (ANDAs) referencing the facility. FDAbasics is not responsible for business losses, delays, or consequential damages resulting from the facility’s placement in arrears. (5) Information Accuracy: Client warrants that all information regarding facility activities and business classifications provided to FDAbasics is truthful and accurate. Misclassification of activities can lead to incorrect fee assessments; FDAbasics is not responsible for fee discrepancies arising from inaccurate Client data. (6) ESG Authorization: To facilitate submissions through the FDA Electronic Submissions Gateway (ESG), the Client agrees to provide an executed Authorization Letter and Letter of Non-Repudiation using templates provided by FDAbasics. (7) FEI Requirement: A valid FDA Establishment Identifier (FEI) is required for GDUFA self-identification. If the facility does not have an FEI, the assignment timeline is controlled by the FDA, and FDAbasics cannot guarantee or expedite this process. (8) Refund Policy: All fees paid to FDAbasics are non-refundable once FDAbasics has commenced work on the project or reviewed Client-provided data. Delays caused by the Client’s failure to provide information in a timely manner shall not be deemed a service failure by FDAbasics. (9) No Legal Advice: Any guidance provided by FDAbasics regarding GDUFA fee structures or classifications is for general informational purposes only and does not constitute a legal opinion or legal advice.
36. FOOD FACILITY REGISTRATION SERVICES (1) Registration Authority: Client authorizes FDAbasics, their employees, and associates to submit, update, or modify the food facility registration on their behalf. Client confirms they have been authorized by the operator/owner of the facility to submit such registration. (2) No FDA Certificate: Client acknowledges that the FDA does not issue certificates for food facility registration. Any certificate provided by FDAbasics is for reference and business facilitation purposes only and does not constitute an official government document. (3) UFI/DUNS Requirement: A valid DUNS number (Unique Facility Identifier) is mandatory for registration. If Client does not have a DUNS number, separate application assistance is available for an additional fee. Failure to provide a valid DUNS within 60 days may result in the cancellation of the registration. Client understands that UFI verification timing is controlled by the FDA/UFI database, and FDAbasics has no control over this process. (4) Ongoing Update Responsibility: It remains the Client's responsibility to notify FDAbasics of any changes to facility address, contact information, or ownership. FDAbasics' services are limited to the initial registration or specific update services contracted and paid for. (5) Biennial Renewal: Food facility registrations must be renewed biennially (every two years) during the FDA renewal period (October 1 – December 31 of even-numbered years). FDAbasics has no obligation to remind Client of renewal deadlines unless separately contracted for renewal services. (6) Information Accuracy: Client shall provide FDAbasics with all information and materials requested to fulfill the responsibility of food facility registration. The Client warrants that all information provided is accurate, truthful, genuine, and current. (7) No Product Liability: Client acknowledges that FDAbasics has no involvement in or specific knowledge of the products manufactured or distributed by the facility. The Client shall not hold FDAbasics liable for any negligence or damages arising from the performance, marketing, labeling, safety, or listing of the products. (8) FDA Cancellation: Client agrees that the FDA may cancel a registration for various reasons (e.g., UFI database mismatches or non-compliance). FDAbasics shall not be responsible for any damages or consequences caused by such FDA-initiated cancellations. (9) FSVP & U.S. Agent DUNS Restrictions: Client shall not use FDAbasics’ DUNS number for FSVP importer identification purposes. Client must not use FDAbasics as an FSVP Agent without a separate, valid FSVP Agent contract. (10) Fees: All fees are non-refundable. FDAbasics reserves the right to cancel the registration or withdraw services if the Client fails to renew the contract. (11) Additional Terms for Foreign Facilities Only (a) U.S. Agent Appointment: Pursuant to FDA regulations, the Client hereby appoints FDAbasics to act as the U.S. Agent for the food facility only. (b) Communication Medium: The purpose of the U.S. Agent is to act as a medium of communication between the FDA and the foreign food facility for both routine and emergency communications. (c) Scope of Responsibility: Client shall provide all information necessary for FDAbasics to fulfill its regulatory responsibilities as the registered U.S. Agent and Official Correspondent. This appointment does not include any other regulatory consulting services.
37. FEI Number Requests:  If Client engages FDAbasics for FEI (FDA Establishment Identifier) number application assistance, Client acknowledges: (i) Client authorizes FDAbasics and its associates to submit the FEI number application and/or inquiry on behalf of the firm. Client affirms they are a duly authorized representative of the company with the authority to request or update an FEI number. (ii) Client agrees that all information provided is truthful, accurate, and complete. If an application is delayed or rejected due to incorrect or insufficient data provided by the Client, such an occurrence shall not be considered a failure of service by FDAbasics. (iii) The fee paid is a service charge for FDAbasics’ consulting and facilitation services. This fee is non-refundable unless FDAbasics fails to perform the requested submission. (iv) The timeline for FEI assignment is dictated solely by the FDA’s internal response times and protocols, which can take up to 2 weeks. FDAbasics maintains no authority over the FDA’s schedule and cannot guarantee a specific delivery date. (v) Client acknowledges that the ultimate issuance and assignment of an FEI number are at the sole discretion of the FDA. FDAbasics is a private consulting firm and is not affiliated with the FDA. (vi) If the Client fails to provide requested information in a timely manner, FDAbasics is not liable for any resulting delays or the inability to complete the application.
38. Prior Notice of Imported Food: (1) Scope of Service: FDAbasics will provide technical assistance in the electronic submission of Prior Notice to the U.S. Food and Drug Administration (FDA) and/or U.S. Customs and Border Protection (CBP) for the shipment(s) identified in the invoice. (2) Client Responsibility for Data: The Client is solely responsible for providing FDAbasics with truthful, accurate, and complete shipment data, including but not limited to: Product Description, FDA Product Code, Country of Production, Manufacturer/Grower details, Shipper/Carrier information, and estimated arrival time. (3) Submission Deadlines: Per FDA regulations (21 CFR 1.279), Prior Notice must be submitted and confirmed within specific windows before arrival (e.g., at least 2 hours for road, 4 hours for air/rail, and 8 hours for water). FDAbasics requires all shipment documentation to be submitted to us at least 24 business hours prior to the estimated arrival at the port. FDAbasics is not responsible for shipment delays or refusals if data is provided outside of this window. (4) No Guarantee of Entry: Submission of Prior Notice by FDAbasics is a regulatory filing requirement and does not constitute a guarantee of U.S. Customs clearance or FDA entry. The FDA and CBP retain the sole authority to inspect, hold, or refuse any shipment. (5) Liability for Refusal/Holds: FDAbasics shall not be held liable for any consequential damages, storage fees, demurrage charges, or losses arising from a shipment being held, refused, or destroyed by the FDA or CBP. This applies regardless of whether the hold is due to data errors, random inspections, or facility registration status. (6) Prior Notice Confirmation (PNC): FDAbasics will provide the Client with the Prior Notice Confirmation (PNC) Number. It is the Client’s responsibility to ensure this number is provided to the carrier and accompanies the shipment documentation as required by law. (7) Facility Registration Requirement: Prior Notice cannot be successfully submitted without a valid FDA Food Facility Registration (FFR) number for the manufacturer. If the manufacturer’s registration is invalid or canceled, FDAbasics cannot complete the filing. (8) Refund Policy: Fees paid to FDAbasics for Prior Notice submission are for professional service charges and are non-refundable once the submission has been filed with the FDA/CBP gateway. (9) Role Clarification (Not an Importer/FSVP Agent): Client acknowledges that FDAbasics is acting solely as a third-party transmittal service for the electronic filing of Prior Notice. FDAbasics is NOT the "Initial Importer," "Importer of Record," or the "FSVP Agent" (as defined by 21 CFR 1.500) for the shipment. The Client or the designated FSVP agent retains all legal responsibility for FSVP compliance, including supplier verification and hazard analysis. FDAbasics does not take legal title to the goods, nor does it assume any risk or responsibility for the safety, quality, or admissibility of the products into the United States.
39. FSVP Services (1) Scope of Services: FDAbasics’ role is limited to performing the regulatory functions of a U.S. FSVP Agent, which includes reviewing food safety plans, performing supplier risk assessments, and maintaining required verification records. (2) No Pre-Contractual Agency: Relationship Completion of any screening form, assessment, or questionnaire does not constitute the establishment of an agency relationship. Client is strictly prohibited from identifying FDAbasics as their designated FSVP Agent on any FDA, Prior Notice, or U.S. Customs documentation until a formal FSVP Agency Agreement is fully executed by both parties. (3) Client Warranty of Data Integrity: Client warrants that all information, safety data, and technical documentation provided to FDAbasics during the screening, assessment, and ongoing shipment phases are truthful, accurate, and complete. FDAbasics relies exclusively on this data to fulfill its federal mandate. Providing incorrect or fraudulent information is a violation of federal law and will result in the immediate termination of services. (4) Authorization for FDA Disclosure: Pursuant to 21 CFR 1.510, FDAbasics is required to make FSVP records available to the U.S. Food and Drug Administration (FDA) upon request. Client hereby authorizes FDAbasics to provide any information, records, or food safety documentation submitted by the Client to the FDA during a regulatory inquiry, inspection, or as required by law. (5) Product Classification & Claim Warranty: Client warrants that all products submitted for FSVP verification are intended for use as food or dietary supplements and do not make any disease-prevention, disease-curing, or unapproved drug-related claims. FDAbasics reserves the right to refuse agency services for any product that, in its sole discretion, is misclassified or makes non-compliant regulatory claims. (6) Verification and Right of Refusal: FDAbasics retains the absolute right to refuse FSVP Agent services or reject specific shipments based on the findings of its risk assessments. If a manufacturer’s food safety plan, audit results, or compliance history (such as Import Alerts) do not meet FDAbasics’ internal safety standards, FDAbasics may decline the appointment or terminate the agreement. (7) Per-Shipment Compliance: For every shipment where FDAbasics is identified as the FSVP Agent: (a) Client must ensure the shipment matches the verified manufacturing facility and product description. (b) Client must notify FDAbasics if the annual sales volume exceeds the thresholds established in the most recent Agency Agreement. (c) FDAbasics reserves the right to reject any shipment that does not align with previously verified FSVP records. (8) Role Clarification & Logistics Disclaimer: FDAbasics is a regulatory compliance firm and is NOT a customs broker, freight forwarder, or initial importer. FDAbasics is not responsible for: (a) U.S. Customs clearance, duties, or taxes. (b) Port of entry holds, storage fees, or demurrage charges. (c) Physical distribution, logistics, or quality-related issues. (d) Mandatory reporting of serious adverse events (unless separately contracted). (9) Refund and Cancellation Policy: Service fees paid to FDAbasics are for professional consultation and regulatory review. Fees are non-refundable once FDAbasics has commenced the review of Client data or initiated the verification process. FDAbasics is not liable for business losses or shipment delays resulting from incomplete data provided by the Client or FDA-imposed holds. (10) Indemnity and Release of Liability Client agrees to assume all risk and hereby releases Pragmatic Compliance Inc (DBA FDAbasics), its officers, directors, and employees from any and all liability. Client shall hold harmless and indemnify FDAbasics against any and all claims, fines, penalties, or legal actions arising from the product’s safety, manufacturing, marketing, labeling, or regulatory status with the FDA or U.S. Customs.
40. HAND SANITIZER AND ALCOHOL-BASED DRUG PRODUCT SERVICES (A) Hand sanitizers and alcohol-based antiseptic products are regulated as over-the-counter (OTC) drugs by the FDA. (B) Services include drug establishment registration, product listing, NDC assignment, and label compliance review as specified in the invoice. (C) FORMULATION CHANGES. Any change to the active ingredient concentration, inactive ingredients, or product formulation constitutes a new drug product and requires a new listing with separate fees (D) LABELING REQUIREMENTS. Hand sanitizer labels must comply with FDA's OTC Monograph requirements and include required warnings,