21 CFR Part 1 Subpart L - Foreign Supplier Verification Programs for Importers

What it says

Importers of food for humans and animals must develop, maintain and follow a Foreign Supplier Verification Program for each food and foreign supplier, which includes a hazard analysis, an evaluation of the foreign supplier's performance and the food's risks, supplier verification activities, corrective actions and records, all carried out under a qualified individual. Modified requirements and exemptions apply to certain foods and importers.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The importer, not the foreign supplier, holds the responsibility here, so a US company buying from overseas must be able to show the food it imports is produced to US safety standards.
• Verification activities are matched to the hazard, and can include onsite audits, sampling and testing, and review of the supplier's food safety records.
• Importers must provide their identification information at entry, so FDA can link imported food to the responsible importer.

What FDA inspectors look for

• Whether a written program exists for each food and foreign supplier.
• Whether the importer evaluated the supplier and chose verification activities appropriate to the hazard.
• Whether corrective actions were taken when a supplier did not meet requirements.

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