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IMA Wellness Blog

FDA Publishes List of Required FSVP Records

by Shari Wright

Husch Blackwell LLP is an IMA B2B Partner

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP).

The document contains a detailed checklist of the records required to be maintained by an importer.  However, not every record included in the checklist is applicable to every importer.

Under FSVP, importers are required to verity that the foods they are importing into the U.S. have been produced in a manner that meets applicable U.S. food safety standards, namely the Food Safety Modernization Act. Importers are required to develop, implement, and maintain an FSVP that includes conducting and documenting verification activities, such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records, that are based on risks linked to the imported food and the performance of the supplier.

The list issued by FDA should be a useful to assist importers with compliance with the regulations as the regulation does not include a list of the specific records that are required to be maintained. It may also help FDA investigators during inspections.

FDA is actively inspecting importers and enforcing the FSVP regulation. Since FY 2017, FDA has conducted 1,584 FSVP inspections and issued one Warning Letter for an importer’s failure to develop an FSVP. In Fiscal Year 2018, the failure to develop an FSVP was the most commonly cited observation in the food program. FDA has previously stated that, going forward, FDA’s focus will shift to ensuring compliance with the FSVP requirements. This will include re-inspecting importers that had deficiencies in previous inspections and taking immediate action when FSVP deficiencies are found that pose an imminent public health risk.

To view the original article, click here.