FSVP Compliance Checklist for U.S. Food Importers
FSVP Compliance Checklist for U.S. Food Importers
38 verification points across 5 sections · Click each item to mark it complete
How to use this checklist: Each item maps to a specific FSVP requirement under 21 CFR Part 1, Subpart L. Items marked CRITICAL are non-negotiable — a single gap here can trigger an import alert or Warning Letter. Use this as a self-assessment before an FDA inspection or when onboarding a new foreign supplier.
1 — Qualified Individual & Agent Designation0/6
✓
A qualified individual has been formally designated as the FSVP Agent (must meet the «qualified individual» definition per 21 CFR 1.500)
Critical✓
The FSVP Agent has completed FSPCA FSVP training recognized by FDA, or has equivalent documented food safety knowledge and experience
Critical✓
Written documentation confirms the agent’s name, qualifications, and role within the FSVP program
§1.509✓
The FSVP Agent is reachable by FDA during business hours and can respond to agency inquiries in English
✓
Your FDA Importer Account (via FDA Unified Registration and Listing System or CBP) accurately reflects your FSVP Agent’s contact information
CBP✓
There is a documented process for updating the agent designation when personnel changes occur
2 — Foreign Supplier Evaluation0/9
✓
A written hazard analysis has been completed for each food commodity imported, identifying known or reasonably foreseeable biological, chemical, and physical hazards
Critical✓
Each hazard identified as requiring a control measure is documented with the rationale for that determination
Critical✓
A foreign supplier evaluation has been conducted for each supplier, assessing their food safety practices and performance history
Critical✓
Supplier evaluation considers: FDA inspection history, compliance with applicable U.S. food safety regulations, and corrective action track record
§1.505✓
If the supplier holds a recognized certification (e.g., PrimusGFS, SQF, GlobalG.A.P.), this is documented and the certification scope is verified against the imported product
✓
The evaluation assesses the severity and probability of hazards if controls are not applied
✓
Supplier evaluation records are maintained and dated, with the name of the qualified individual who performed the evaluation
Records✓
There is a process to re-evaluate suppliers when new information emerges about food safety risks or supplier performance
✓
You have obtained and reviewed supplier documentation: certificates of analysis, food safety plans, audit reports, or equivalent evidence
3 — Verification Activities0/9
✓
Verification activities have been determined and documented for each supplier, appropriate to the hazards and supplier risk level
Critical✓
For suppliers with hazards that require control, verification includes at least one of: onsite audit, sampling & testing, review of food safety records, or other appropriate activity
Critical✓
If relying on a third-party audit as verification, the auditor is qualified and the audit scope covers the relevant hazards
§1.506✓
If using product testing as verification, sampling plans, testing methods, and frequency are documented and scientifically appropriate
✓
If relying on a supplier’s food safety records review, the records reviewed are specified and the review frequency is documented
✓
Verification activities are conducted at an appropriate frequency based on risk — and not just at onboarding
✓
All verification activity results are documented with dates and outcomes, and records are retained for at least 2 years
Records✓
There is a documented process to respond to unsatisfactory verification results — including supplier corrective action requests and stop-ship decisions
✓
If a supplier has been approved under an exemption or modified requirement (e.g., very small supplier), the basis for that exemption is documented
§1.5074 — FSVP Program Documentation & Annual Review0/8
✓
You have a complete written FSVP program covering all required elements under 21 CFR Part 1, Subpart L
Critical✓
The FSVP program has been reviewed and reanalyzed within the past 12 months by a qualified individual
Critical✓
The program was updated whenever you became aware of new information about food safety risks for any imported product
§1.510✓
The program was updated when you added new products or new foreign suppliers
✓
All FSVP records are maintained in English (or translated into English) and can be provided to FDA within 24 hours of a request during inspection
Records✓
Records are retained for at least 2 years (certain records require longer retention — confirm by record type)
Records✓
There is a corrective action procedure when the FSVP program is found to be inadequate or when a supplier fails to meet requirements
✓
You know what to do if you receive a Form 483 or Warning Letter related to your FSVP — and you have a designated point of contact to respond
5 — Exemptions, Waivers & Special Situations0/6
✓
You have confirmed whether each imported food is subject to FSVP or exempt (e.g., juice under 21 CFR Part 120, seafood under Part 123, dietary supplements under Part 111)
§1.502✓
If importing from a country with an FDA equivalence recognition agreement, you have documented the basis for relying on that recognition
✓
If any supplier qualifies as a very small foreign supplier (annual sales ≤$1M), you have documented the modified verification approach applied
§1.512✓
You have assessed whether any imported product is a RAC (raw agricultural commodity) and applied the correct FSVP requirements accordingly
✓
If a broker or customs agent is involved in your imports, their role relative to FSVP obligations is clearly defined and does not create compliance gaps
✓
You have a process to monitor FDA import alerts affecting your suppliers or products, and to act on them before shipments are presented at the border
✅
Full FSVP Compliance — Well Done
You’ve checked all 38 requirements. Maintain your program active throughout the year and schedule your annual reanalysis before it’s due.
Talk to an FSVP Expert at Agrocers →