“FSVP is the US importer’s responsibility — it has nothing to do with us as the exporter, right?” a Kaohsiung maker of handmade sauces asked us. Legally he was half right: FDA does place the Foreign Supplier Verification Program (FSVP) on the importer located in the United States. In practice, though, the party the importer has to verify is you, and every document in the importer’s file has to come from you. FSVP is the importer’s obligation, but the homework belongs to the exporter.
What FSVP actually verifies
The logic of FSMA (the Food Safety Modernization Act) is simple: the US cannot regulate a foreign plant, so it regulates the American who brings the food in. FSVP requires the importer to use a risk-based approach to prove three things: this foreign supplier knows which hazards its product carries, has controls for those hazards, and actually runs those controls.
So FSVP is not a certificate; it is an ongoing verification procedure. The importer must be able to produce records at every import and at every annual review. FDA audits the importer, but what it audits is your plant.
The importer’s five obligations
Under FDA rules, what an FSVP Importer has to do can be summed up in five items:
- Hazard analysis: evaluate the biological, chemical and physical hazards of the food one by one, including allergens and economically motivated adulteration. The importer can do this itself, or review and adopt the hazard analysis the supplier provides
- Evaluate supplier performance and risk: the supplier’s food-safety history, FDA warning letters, import alerts, past test results
- Determine and conduct verification activities: depending on risk, an annual on-site audit, lot-by-lot testing, a review of food-safety records, or a combination; serious hazards normally call for an on-site audit
- Corrective actions: a procedure to stop importing or require improvement when the supplier is found non-compliant
- Reassessment and record keeping: reassess every three years or whenever the supplier changes significantly; keep all records for at least two years and provide them in English within 24 hours when FDA asks
The importer itself also needs a DUNS number, entered at customs entry — this is how FDA identifies the FSVP Importer.
The six documents a Taiwanese exporter must hand over
Turn the importer’s obligations around and you get the exporter’s document list:
- Hazard analysis or Food Safety Plan: a HACCP plan is a good base, but it must be extended with the preventive controls FSMA requires
- Process and preventive-control records: CCP monitoring, temperature logs, metal detection, cleaning and sanitation records
- Third-party test reports: microbiology, heavy metals and pesticide-residue reports from SGS, TÜV and the like, by product category
- Allergen control procedure: the US has nine major allergens (including sesame); both labeling and cross-contact control need records
- Your own supplier list: raw-material sources and their test certificates
- Facility registration and certifications: FDA facility registration number, ISO 22000 or FSSC 22000 certificate if you have one
A frozen-seafood plant in Tainan was asked by its US importer, on its first shipment, for “microbiological test results for every lot over the past year.” The plant only had a spot-check report every six months, and the back-and-forth took three weeks. From the second shipment on it attached a test report to every lot, and customs never held it again.
What if the importer refuses to take on FSVP?
This is where Taiwanese exporters most often get stuck: the US buyer wants to purchase but does not want to be the FSVP Importer, because that means being audited by FDA, keeping records and carrying the liability. The solution the rules allow is to appoint an “FSVP Agent” located in the US, who files as the FSVP Importer and accepts the audits.
SKYCARGO INC is registered in the United States and holds FDA and USDA agent status. We can act as Importer of Record and consignee, and help prepare the hazard analysis and verification records FSVP needs for your product category; once the cargo reaches our Oregon or Los Angeles warehouse we handle inspection and delivery. Taijiang milkfish and GoodMall scallion pancakes both went through exactly this way.
What FDA looks at during an audit
When FDA audits an FSVP Importer it does not visit your plant in Taiwan; it asks the importer to produce records. The three most requested items: the hazard analysis, evidence of supplier verification activities (audit report or lot testing), and corrective-action records. If one is missing, the importer can be listed as “FSVP non-compliant,” and later shipments face intensified inspection or refusal.
So rather than waiting for the importer to ask, assemble the six documents into one package before you ship — in English, updated by lot. With that package ready, you can switch to any importer and hand it straight over.
This article summarizes FDA 21 CFR Part 1 Subpart L (FSVP) for reference only. Always check the latest FDA announcements.
