San-Rey Produce Inc. – FDA Warning Letter, Aug 19, 2022

On December 7, 2022, the FDA issued a Warning Letter to SAN-REY PRODUCE INC, following Foreign Supplier Verification Programs (FSVP) inspections on August 11 and 19, 2022, and November 13, 2020. The inspections, conducted at 10101 S. Keystone Dr., Pharr, Texas, aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The FDA found significant violations, specifically that SAN-REY PRODUCE INC did not develop, maintain, or follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This means the company failed to demonstrate that its suppliers produce food in compliance with U.S. food safety standards, particularly those under section 419 of the FD&C Act and 21 CFR part 112.

The company's September 6, 2022, response to the FDA 483a was deemed inadequate due to a lack of supporting documentation or specific steps taken to address the violations.

Failure to adequately address these issues may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert