FDA Import Alert 99-41 Reminds Buyers: FSVP Supplier Verification Requires More Than a Certificate
A verification plan should explain risks, actions, frequency, and corrective outcomes
FSVP focuses on an ongoing process
The FDA's publication list shows that Import Alert 99-41 was updated on September 22 and concerns noncompliance with the Foreign Supplier Verification Program. A single factory certificate does not show that an importer has identified hazards, selected control measures, and kept reviewing the results.
Key point: Importers need verification files for each product and supplier. They should set the frequency of audits, sample testing, and document reviews based on risk.
A practical verification file
| Section | What to record | When to update |
|---|---|---|
| Hazard analysis | Biological, chemical, and physical hazards | Changes to the formula or process |
| Supplier evaluation | Compliance history, capabilities, and control measures | A new supplier or a major problem |
| Verification activities | Audits, sample testing, and COA reviews | At the frequency set by risk and the plan |
| Corrective actions | Segregation, investigation, and renewed verification | Nonconformities or complaints |
Procurement and compliance teams should use the same supplier code. This allows orders, tests, complaints, and corrective actions to be linked to the same file.
Scope and limits
FSVP responsibilities and exemptions depend on the importer, product, and transaction structure. Businesses should have someone familiar with U.S. food regulations confirm which requirements apply.
FAQ
1. Can a GFSI-recognized certificate replace FSVP?
It cannot directly replace FSVP. It can form part of the evidence used in an evaluation.
2. Does every batch need testing?
The testing frequency should reflect the hazards and supplier risk. The reasons for that frequency should be documented.
3. Who should be verified when a trading company supplies the goods?
The importer needs to identify the actual producer and confirm that verification activities cover the relevant risks.
What procurement teams can do now
Teams can first classify all foods currently sold by risk, then check whether each high-risk product has current, valid supplier verification records.
Stellar.shop content suggestion: Show the most recent evaluation, verification method, next review date, and open issues on the supplier page.