Foreign Supplier Verification Programs · 21 CFR part 1, subpart L
FSVP supplier evaluation: checking a supplier's FDA compliance
Under FSVP, a U.S. importer of food must evaluate each foreign supplier before approving it. Part of that evaluation is the supplier's FDA compliance record. This page sets out what the rule says about that part, and how to document it.
What the rule asks
When approving a foreign supplier, the importer must consider the supplier's performance, including its compliance
with FDA food safety regulations and whether the foreign supplier is the subject of an FDA warning letter, import
alert, or other FDA compliance action related to food safety
.
That sits beside the other things the evaluation must consider: the hazard analysis for the food, which entity controls those hazards, the supplier's own procedures and food safety history, and factors such as storage and transport. The evaluation must be documented.
How often
- Before approval. Suppliers are approved on the basis of the evaluation.
- Promptly, when new information comes to light about the supplier's performance, such as a new import alert or warning letter.
- At least every three years otherwise.
What to keep
FSVP records must be signed and dated when first completed and whenever they change, and kept for at least two years after they were created or obtained.
Where FDA publishes the compliance record
In five separate places: import alerts, import refusals, inspection classifications, warning letters and compliance actions, and recalls. Refusals, inspections and compliance actions identify a facility by its FDA Establishment Identifier; import alerts, warning letters and recalls give only a name and an address, often spelled differently from your invoice. Checking a supplier properly means searching all five under every likely spelling.
How Supplier Brief fits
Supplier Brief searches all five at once and links each record to the firm it is about (how). The Supplier FDA Record ($29) puts the result on paper for your file: what was searched and when, what was found, what was considered and not counted, how fresh each source was, and a block for your qualified individual to sign and date.
It covers the FDA compliance part of the evaluation only. It is not an evaluation by a qualified individual, and it does not assess the hazards, the supplier's practices or your verification activities.
The FDA-compliance part of your evaluation, on one page.
Free to search across all five FDA sources. $29 for the dated, signable record.