FSVP basics for food importers

The Foreign Supplier Verification Program (FSVP) is an FDA rule under FSMA (21 CFR part 1, subpart L). For each food you import, you must develop, maintain, and follow an FSVP that gives adequate assurances that your foreign supplier produces the food to US food safety standards (21 CFR 1.502(a)).

Who must comply:

• The importer, meaning the US owner or consignee of the food at the time of entry: the person in the United States who owns the food, has bought it, or has agreed in writing to buy it (21 CFR 1.500)
• If there is no US owner or consignee at entry, the importer is the US agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent to serve as the importer (21 CFR 1.500, 1.509(b))
• Some foods are exempt, such as certain juice and seafood covered by FDA's HACCP rules, food for research or personal use, and alcoholic beverages (21 CFR 1.501)

Required activities (high level):

1. Conduct a written hazard analysis for each type of food (21 CFR 1.504)
2. Evaluate the food and the foreign supplier, including the supplier's performance, to approve suppliers and choose verification activities (21 CFR 1.505)
3. Carry out supplier verification activities: onsite audits, sampling and testing, review of the supplier's food safety records, or other appropriate activities (21 CFR 1.506)
4. Take corrective actions when a supplier isn't meeting the standard (21 CFR 1.508)
5. Identify yourself as the importer when entry is filed with CBP: your name, email, and unique facility identifier for each line entry (21 CFR 1.509(a))
6. Use a qualified individual to develop the FSVP and perform its activities (21 CFR 1.503)
7. Keep records for at least 2 years (21 CFR 1.510(c))

INFO: Food whose importer doesn't comply is subject to refusal of admission (21 CFR 1.514(a)), and importing food without an FSVP that meets the requirements is a prohibited act (21 CFR 1.514(b)). On the Pro plan, Aleph's FSVP page can assemble the records you've kept for the products you choose into an inspection package you can download or send.