FDA WARNING_LETTER - FVD Produce, LLC - March 09, 2023

On August 15, 2023, the FDA issued a Warning Letter to FVD Produce, LLC, following a Foreign Supplier Verification Program (FSVP) inspection conducted from February 8 to March 9, 2023, with a prior inspection on May 20, 2021. The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, as the company failed to develop, maintain, and follow an FSVP for imported foods, including "covered produce."

Specifically, FVD Produce, LLC did not provide a complete FSVP for any imported foods. While some certificates for past foreign suppliers were provided, they were incomplete, lacked review records, and were from suppliers no longer used. The company imports fresh produce, which requires an FSVP demonstrating compliance with U.S. food safety standards, including those under 21 CFR part 112 (Standards for Produce Safety).

The FDA noted that a Form FDA 483a FSVP Observations was issued on March 9, 2023, and no response had been received. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) via Import Alert # 9