FSVP — the Foreign Supplier Verification Program — is an FDA regulation requiring U.S. importers of human and animal food to verify that their foreign suppliers produce food in compliance with applicable U.S. food safety requirements. Codified at 21 CFR Part 1, Subpart L (sections 1.500 through 1.514), FSVP was issued under Section 301 of the FDA Food Safety Modernization Act (FSMA), which added Section 805 to the Federal Food, Drug, and Cosmetic Act. For each combination of food and foreign supplier, the FSVP importer must: identify a Qualified Individual, perform a hazard analysis, evaluate and approve the foreign supplier, conduct appropriate verification activities, take corrective action when problems arise, provide importer identification at every entry (including a DUNS number), and reanalyze the program at least every three years.

The FSVP importer is the U.S. owner or consignee of an article of food at the time of entry; if no U.S. owner or consignee exists, the FSVP importer is the U.S. agent or representative of the foreign owner, designated in writing before entry. This definition appears in 21 CFR 1.500 and is important because the FSVP importer is not always the Importer of Record under U.S. Customs law. Entities subject to FSVP include U.S. importers of human food, animal food and pet food, and dietary supplement ingredients and finished products; brokers, agents, and consignees acting as importer when no U.S. owner or consignee exists; and receiving facilities, which must still meet § 1.509 entry-identification requirements even when compliant with supply-chain provisions of 21 CFR Part 117. 

FSVP exempts foods regulated under parallel U.S. food safety rules and foods that will not enter U.S. commerce, but the exemptions are specific and narrow. Exempt or redirected categories include: juice products subject to 21 CFR Part 120 (juice HACCP) and fish or fishery products subject to 21 CFR Part 123 (seafood HACCP), where importers follow those rules instead; meat, poultry, and egg products regulated by USDA-FSIS rather than FDA; food for research, evaluation, or personal use that is not intended for retail sale; alcoholic beverages from TTB-regulated producers and certain ingredients used in their manufacture; food in transshipment or for export only that never enters U.S. commerce; and low-acid canned foods with respect to microbiological hazards controlled by 21 CFR Part 113 — though FSVP still applies for all other hazards in those products.

A Qualified Individual under FSVP is a person with the education, training, or experience necessary to develop and perform FSVP activities, and who is able to read and understand the language of any records being reviewed. The Qualified Individual is defined in 21 CFR 1.503 and may be an employee of the importer or a contracted third party — the QI does not need to work directly for the company. The FDA-recognized training curriculum is the FSPCA (Food Safety Preventive Controls Alliance) FSVP course, which is the only standardized training developed specifically to meet the training requirements outlined in 21 CFR Part 1, Subpart L. An on-site supplier audit must be conducted by a Qualified Auditor under § 1.506, which requires appropriate technical expertise obtained through education, training, or experience, plus the absence of any disqualifying financial conflict of interest.  

Under 21 CFR 1.504, the FSVP importer must identify and evaluate every known or reasonably foreseeable biological, chemical (including radiological), and physical hazard for each food imported, plus hazards that may be intentionally introduced for economic gain (economically motivated adulteration). The analysis must be based on experience, illness data, scientific reports, and other relevant information, and must determine which hazards require a control. The importer may rely on another entity's hazard analysis — for example, one prepared by the foreign supplier or by a contracted consultant — but must review and assess that analysis in writing, documenting that it was conducted by a qualified individual. For covered produce subject to 21 CFR Part 112 (the Produce Safety Rule), the importer is not required to determine whether biological hazards require a control, because Part 112 compliance addresses those hazards directly.  

Under 21 CFR 1.506, the four FSVP supplier verification activities are: on-site audit, sampling and testing, review of supplier food safety records, and any other appropriate procedure justified by the hazard analysis and supplier evaluation. For SAHCODHA hazards — those that could result in serious adverse health consequences or death to humans or animals — that are controlled by the foreign supplier, an annual on-site audit is the default verification activity, and substituting another activity requires written justification. Sampling and testing is appropriate for many chemical and microbiological hazards and is typically performed by an accredited laboratory. Records review may be sufficient for lower-risk hazards or where a supplier has strong food safety history. Whichever activity is chosen, the rationale must be documented in writing and the activity must match the hazard identified — FDA expects the reasoning, not just the conclusion.

FSVP records must be retained for at least two years after the date they were prepared, kept in English (or accompanied by an English translation), and made available to FDA within 24 hours of request. Required records include: the written FSVP for each food and foreign supplier combination; the hazard analysis; documentation of supplier evaluation and approval with written rationale; determination of appropriate verification activities; audit reports, sampling and testing results, and records review documentation; corrective action investigations and decisions; reanalysis records; FSVP modifications and the basis for them; and any procedures for use of unapproved suppliers on a temporary basis. Supporting documentation must include the Qualified Individual's qualifications, the Qualified Auditor's qualifications and conflict-of-interest disclosures, FSPCA training certificates, DUNS number documentation, and supplier certifications relied upon. Records of supplier evaluations and approvals must be kept while current plus two years after they are superseded.

FDA enforces FSVP through inspections of importer records at the importer's place of business, and non-compliance can result in FDA Form 483 observations, warning letters, import refusal, civil penalties, and in serious cases criminal prosecution under the Federal Food, Drug, and Cosmetic Act. FDA has actively inspected FSVP importers since 2017 and issued its first FSVP warning letter in 2019. Since July 24, 2022, importers must provide a unique facility identifier — typically a DUNS number — at every entry filing under § 1.509; the temporary use of “UNK” as a placeholder is no longer permitted. The most common FSVP citations involve missing or incomplete records rather than missing controls: suppliers marked approved without documented rationale, verification activities chosen for convenience rather than risk, hazard analyses missing the economically motivated adulteration assessment, and reanalysis not performed within the three-year window. FDA inspectors rarely ask theoretical questions — they ask for the record, by name, for a specific food and supplier.