What Is the Foreign Supplier Verification Program and How It Affects Your Exports to the US

The Foreign Supplier Verification Program (FSVP) is one of the most consequential FSMA rules for foreign food manufacturers, yet it is one of the least understood — primarily because it places its legal obligations on the US importer rather than on the foreign supplier. Under 21 CFR Part 1, Subpart L, every US importer of food must develop and maintain an FSVP for each food they import and each foreign supplier they import from. The program requires the importer to evaluate the risks posed by the food, evaluate the performance of the foreign supplier, and conduct verification activities to ensure the food meets US safety standards. While the foreign manufacturer is not directly subject to FSVP enforcement, the program creates powerful indirect obligations — because a foreign manufacturer that cannot provide adequate food safety documentation will lose its US import partners.

What the FSVP importer must do

The FSVP importer — defined as the US owner or consignee of the food at the time of entry, or if there is no US owner or consignee, the US agent or representative of the foreign owner — must conduct a hazard analysis for each food imported. The hazard analysis must evaluate known or reasonably foreseeable biological, chemical, and physical hazards to determine whether there are hazards requiring a control. If hazards are identified, the importer must evaluate the foreign supplier's performance, including the supplier's compliance history, the results of any FDA or third-party audits, and the supplier's food safety practices. Based on this evaluation, the importer must determine and conduct appropriate supplier verification activities.

Supplier verification activities

The verification activities available to importers under FSVP include on-site audits of the foreign supplier's facility, sampling and testing of the food, review of the supplier's relevant food safety records (including food safety plans, HACCP plans, monitoring records, and corrective action records), and other appropriate verification activities. The choice of verification activity must be based on the risk of the food and the supplier's performance — higher-risk foods and lower-performing suppliers require more rigorous verification. For foods with hazards that require a control, at least one of these verification activities must be conducted before importation and on an ongoing basis afterward.

On-site audits are not required for every food or every supplier, but the FDA has made clear in guidance documents that on-site audits are the most effective verification activity for high-risk foods. When an on-site audit is warranted, it must be conducted by a qualified auditor — someone with the education, training, and experience necessary to perform audits of food safety systems. The audit must cover the supplier's compliance with FDA requirements, including applicable preventive controls, HACCP, or produce safety standards.

What foreign suppliers must provide

While FSVP does not directly regulate foreign suppliers, the program effectively requires them to maintain and share extensive food safety documentation. US importers conducting FSVP will request copies of the supplier's food safety plan (or HACCP plan), monitoring records showing that preventive controls or CCPs are being managed, corrective action records from any deviations, third-party audit reports (GFSI-benchmarked certifications such as BRC, SQF, FSSC 22000, or IFS), laboratory test results for pathogens, allergens, chemical contaminants, and other relevant parameters, and documentation of the supplier's food safety training programs. A foreign supplier that cannot produce these documents promptly and in a format that the US importer can evaluate will struggle to maintain US import relationships.

FDA enforcement of FSVP

FDA has actively enforced FSVP since 2017, conducting thousands of FSVP inspections of US importers. The agency has issued numerous Warning Letters to importers who failed to develop FSVPs, failed to conduct adequate hazard analyses, failed to perform appropriate verification activities, or failed to maintain required records. When an importer's FSVP is found deficient, the consequences extend to the foreign supplier — if the importer cannot verify the supplier's food safety program, the importer may stop importing from that supplier, and FDA may increase scrutiny of all shipments from the foreign facility through its PREDICT risk-scoring system. In some cases, FDA FSVP enforcement has resulted in import refusals of all products from specific foreign suppliers.

How FDABridge helps foreign suppliers prepare for FSVP

FDABridge helps foreign food manufacturers maintain the FDA registrations, compliance documentation, and food safety records that US importers need for FSVP compliance. Our services ensure your facility registration is current, your US Agent is properly designated, and your documentation is organized to support your US importer's verification activities. Visit fdabridge.com/food to see our food services or fdabridge.com/contact to discuss your FSVP readiness.