EH Maldonado and Company – FDA Warning Letter, Apr 28, 2022

On July 28, 2022, the FDA issued a Warning Letter to EH Maldonado and Company following a Foreign Supplier Verification Program (FSVP) inspection on April 28, 2022, and a previous inspection on November 17, 2020. The inspection found the company not in compliance with 21 CFR part 1, subpart L, and section 805 of the FD&C Act, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). An FDA Form 483a FSVP Observations was issued on April 28, 2022, to which no response was received.

The FDA noted that the imported fresh produce is "covered produce" (21 CFR 112.3), requiring the FSVP to demonstrate supplier compliance with produce safety standards (21 CFR part 112). Failure to address these violations may result in refusal of admission of imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz).