Select Produce LLC – FDA Warning Letter, Sep 12, 2022

On January 3, 2023, the FDA issued a Warning Letter to Select Produce LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 29 to September 12, 2022, at their McAllen, TX facility. A previous inspection occurred on August 18, 2020. The inspection found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation was the failure to develop, maintain, and follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This means the company did not demonstrate that its suppliers produce food in compliance with public health protection standards equivalent to those required under section 419 of the FD&C Act and 21 CFR part 112 (Produce Safety Rule). A Form FDA 483a FSVP Observations was issued on September 12, 2022, to which no response was received.

Additionally, the facility is subject to food facility registration requirements under section 415 of the FD&C Act and 21 CFR part 1, subpart H, but had not registered. Failure to register is a prohibited