FSVP GAP ANALYSIS
FSVP Agent and Importer Services for food entering the US.
We help US importers and foreign food manufacturers meet FSVP requirements: building the program, serving as the Qualified Individual, and keeping documentation current year after year.
THE BASICS
What is FSVP?
FSVP stands for the Foreign Supplier Verification Program. It is a rule under the Food Safety Modernization Act (FSMA), enforced by FDA since 2017, that requires US importers to verify their foreign suppliers are producing food that meets US safety standards.
In practice, that means maintaining a written program for each foreign supplier that documents hazard analysis, supplier approval, and ongoing verification activities. FSVP records must be available for FDA review within 24 hours of request, and kept for at least two years.
Most US food importers.
- US companies importing human food, including ingredients
- US companies importing animal food, pet food, and feed
- Importers of dietary supplements from foreign suppliers
- Importers of food contact substances in some cases
Limited categories only.
- Seafood already covered under Seafood HACCP
- Juice already covered under Juice HACCP
- Most alcoholic beverages
- Food imported for research or personal consumption
- Food in transit through the US to another country
What happens if you skip it
Shipments without a valid FSVP at time of entry can be detained at the border, refused entry, or placed on FDA Import Alert. Repeat issues can trigger formal enforcement and, in serious cases, prosecution. The good news: FSVP is a documentation problem, and documentation problems are solvable.
KNOW YOUR ROLE FIRST
Four roles. Often confused.
Very different responsibilities.
Before any FSVP work begins, it has to be clear who is responsible for what. This is where most engagements start.
Foreign Supplier
The facility producing the food abroad. Provides the documentation the FSVP Importer and FSVP Agent need to build the program.
FSVP Importer
The party legally responsible for FSVP compliance at time of entry into the United States. Must be a US-based entity.
Importer of Record
Files entry paperwork with US Customs. A different legal role from the FSVP Importer, with different rules and responsibilities.
FSVP Agent
Builds and maintains the FSVP on behalf of the FSVP Importer. This is FDAbasics.
Confused about which role applies to you? A gap analysis is the fastest way to clarify your situation and identify what documentation you need.
Start with a gap analysis →Some importers face lighter requirements.
Not every importer has to meet the full FSVP rule. FDA recognizes Modified FSVP for several categories where standard requirements are relaxed:
- Very Small Importers Annual food sales averaging under $1 million over the last three years.
- Dietary supplement importers When supplier verification is handled by a downstream customer subject to FDA regulation.
- Food from comparable countries Importers sourcing from countries FDA has officially recognized as having comparable food safety systems.
- Low-acid canned foods For microbiological hazards already covered under separate FDA regulation.
Modified FSVP doesn't mean no FSVP. You still need documentation, just less of it. The right scope depends on your specific situation, your supplier, and your food category.
Find out where you stand →WHAT WE DO
FSVP services for both sides of the supply chain.
Whether you are a US importer responsible for FSVP compliance, or a foreign manufacturer looking to coordinate with your US partners, we tailor the engagement to your role.
For US Importers
If you own or consign the food at time of entry, you are the FSVP Importer. We build and maintain the program for you, serving as the Qualified Individual.
- Hazard analysis specific to your food and country of origin
- Supplier evaluation against FSMA requirements
- Supplier verification (GFSI audits, COAs, on-site reviews)
- Annual updates and three-year reassessments
- Documentation maintained and ready for FDA inspection
For Foreign Manufacturers
If your customers are asking for FSVP documentation, we coordinate with your US importer to make sure the program is built correctly, with you as the supplier of record.
- Documentation review and gap closure support
- Coordination between your facility and the US FSVP Importer
- Translation of audit and food safety documents
- FDA inspection and FSVP audit prep
- US Agent services if you also need facility registration support
HOW IT WORKS
Three steps to start the conversation.
Most engagements begin with a short assessment so we can scope the work accurately. No long sales process.
You complete the assessment
Tell us your role, your food categories, your facilities, and the documentation you already have. Takes about 10 minutes.
We respond with a quote
Within one business day, you receive a flat-fee quote and a clear next step. Pricing varies by facilities, products, and food risk profile.
We build the program
If you proceed, we collect supporting documents, run the gap analysis, and author your FSVP. Typical timeline is three to five weeks.
QUICK ANSWERS
Common questions about FSVP services.