FDA Issues Warnings on Foreign Supplier Verification Program Viol

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FDA Issues Pair of Warning Letters for Violation of FSVP Requirements

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, October 30, 2024

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FDA issued two warnings letters this month for violations of the foreign supplier verification program (FSVP) requirements which are found in section 805 Federal Food, Drug, and Cosmetic Act (codified at 21 U.S.C. 384a) and in the implementing regulations at 21 C.F.R. Part 1, Subpart L.
The first warning letter, issued on October 1, 2024 to Paso Real Produce LLC noted the absence of FSVP documentation for the company’s imported products (avocados and limes) and followed FDA’s issuance of Form 483a FSVP Observations following an August 2024 inspection.
The second warning letter, issued on October 10, 2024, to Future Best Trading Inc. followed July inspections which were initiated following a positive Listeria monocytogenes sample in the company’s imported fresh Enoki mushrooms. Although the company responded to the Form FDA 483a FSVP Observations issued at the conclusion of the July inspection, FDA stated that the documents did not meet FSVP requirements, in part because their relevance was not explained and there was no indication that the company had reviewed or assessed any of the documents as part of the hazard analysis required by FSVP. The letter also noted the FSVP requirement to take prompt corrective action following the Listeria contamination incident and that while certain relevant steps that had been taken (e.g., the supplier’s food safety improvement plan), the corrective actions taken by the company had not been properly documented and incorporated into a FSVP plan.
Both letters warn the companies that continued failure to comply with the FSVP requirements could result in the refusal of admission of food products which appear to violate the FSVP requirements or placement on an import alert list (allowing for detention without physical examination). Import Alert 99-41 includes a list of companies which are not in compliance with the FSVP requirements.