FDA Issues First Warning Letter Under FSVP Regulations

Husch Blackwell LLP

On July 30, 2019, the U.S. Food and Drug Administration (FDA) issued its first Warning Letter to an importer for violations of the Foreign Supplier Verification Program (FSVP) requirements at  21 C.F.R. Part 1, Subpart L (21 C.F.R. §§ 1.500 through 1.514).  The Warning Letter was issued to a U.S. importer related to imported tahini implicated in a multi-state Salmonella Concord outbreak in spring 2019.

FDA stated in the Warning Letter that the importer was not familiar with the FSVP requirements, did not develop an FSVP for the imported tahini, and failed to respond to the FDA investigator’s formal observations during the FSVP inspection. The Warning Letter also noted that the importer’s voluntary recall, by itself, did not address the underlying FSVP violations.

This Warning Letter serves as an important reminder to importers that FDA expects companies to have FSVPs that meet the requirements of 21 C.F.R. Part 1, Subpart L.

FDA has been conducting FSVP inspections since 2017. These inspections have been primarily focused on assisting importers with understanding the FSVP requirements and how to take corrective actions for deficiencies.  In Fiscal Year 2018, the failure to develop an FSVP was the most commonly cited observation in the food program.

In the Press Release accompanying the Warning Letter, FDA has 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.

Importers that fail to take corrective actions for deficiencies identified by FDA during an inspection may also be subject to the newly established Import Alert #99-41, Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation.  Imports offered by an importer on the Red List under this Import Alert would be subject to automatic detention.  Further, such importers would be prevented from participating in the Voluntary Qualified Importer Program (VQIP).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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