FSVP GAP ANALYSIS
Don't know what FSVP actually requires?
Start with a gap analysis.
A clear, scoped review of where your supplier documentation stands today versus what the FDA expects under the Foreign Supplier Verification Program. No guesswork, no jargon, no surprises.
"Did AI tell you you need an FSVP and you have no clue what that means?"
WHY THIS PAGE EXISTS
FSVP is the most misunderstood
rule in food import compliance.
We hear the same questions every week. Here's what's actually true.
"I have ISO 22000 and a HACCP plan. That's enough, right?"
Not on its own. ISO certificates and HACCP plans show good practices, but the FDA requires a separate, US-specific hazard analysis, supplier evaluation, and verification record.
"My customs broker handles this for me."
Different role. A customs broker files entry documents. The FSVP Importer is legally responsible for compliance, and most brokers will not act in that role.
"Can't I just register my facility and start shipping?"
Registration is one step. Every shipment of human food entering the US must also have an FSVP in place at time of entry, or it can be detained.
STEP 1: KNOW YOUR ROLE
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.
STEP 2: WHAT FSVP REQUIRES
Three requirements. One program.
The FDA enforces FSVP through three connected activities. Each has to be documented, defensible, and specific to your food, your process, and your country of origin.
Hazard Analysis
Identify every known and reasonably foreseeable hazard for each food: biological, chemical, and physical.
- Aligned with FDA-recognized hazards (Bad Bug Book, Import Alerts, FDA guidance)
- Supplier's HACCP supports it but does not replace it
- Specific to your food, your process, your country of origin
Supplier Evaluation
Evaluate the foreign supplier's ability to control the hazards you identified.
- HACCP plan and food safety plan
- Sourcing and ingredient controls
- Production flow and process controls
- Sanitation, allergen, and environmental monitoring
- Recall plans, traceability, and compliance history
Supplier Verification
Confirm with evidence that the supplier is doing what they say.
- Current GFSI-recognized audit (SQF, BRCGS, FSSC 22000, IFS, GlobalG.A.P., PrimusGFS)
- Product testing and Certificates of Analysis (COAs)
- On-site audits when audits aren't available or risk is elevated
Common gaps we see. ISO 9001, ISO 22000, GMP, and standalone HACCP certificates are not sufficient on their own. They show good practices, but the FDA requires the full hazard analysis, supplier evaluation, and verification documentation described above.
WHAT A GAP ANALYSIS ACTUALLY DOES
A side-by-side check of what you have versus what the FDA requires.
Most clients come to us with a stack of certificates, audit reports, and HACCP documents. Some of it counts toward FSVP. Some of it doesn't. The gap analysis tells you which is which, in plain language, before you spend money on the full FSVP build.
STEP 3: OUR PROCESS
Predictable steps from kickoff to ongoing compliance
A gap analysis is steps 1 through 3. If you decide to continue, we move into FSVP authoring and ongoing maintenance.
Assessment
We review your scope and provide a flat-fee quote to begin.
Document collection
You complete a questionnaire and provide supporting documents.
Gap analysis
We identify what's missing or insufficient against FSVP requirements.
FSVP authoring
We write your full FSVP as the Qualified Individual.
Annual check-in
We refresh your FSVP with updated COAs, audits, and process changes.
Robust update
Full reassessment to ensure ongoing compliance as risks evolve.
PRICING APPROACH
Transparent, scope-based fees, quoted upfront.
Every engagement is quoted upfront after an initial assessment. Pricing is flat-fee, not hourly, and varies based on three factors:
Number of facilities
Each manufacturing site requires its own evaluation and verification.
Number of products
Each food product has its own hazard analysis and supplier verification activities.
Food risk level
Determined by food type and country of origin. Higher-risk foods require deeper verification.
If the gap analysis identifies significant issues, FSVP authoring is paused until gaps are closed. Gap-closure work is scoped and quoted separately.
GET SCOPED
Start your FSVP gap analysis.
Tell us a bit about your role and your operation. We'll review what you've shared, and within one business day we'll respond with a flat-fee quote and the next steps.
Which best describes you?
Choose what fits best, and we'll open the right intake form for you.
Want to share this with your team or supplier?
Download our 8-page FSVP overview, the same document we use to walk new clients through their first compliance conversation.