FDA WARNING_LETTER - DEL VALLE IMPORT CORP. - August 17, 2022

On July 7-August 17, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Del Valle Import Corp. at 1231 Lafayette Avenue, Bronx, NY. A previous inspection occurred July 7-August 23, 2021. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate risk-based activities to verify imported food meets U.S. food safety standards.

The most recent inspection found Del Valle Import Corp. not in compliance with 21 CFR part 1, subpart L, constituting significant violations of section 805 of the FD&C Act. An FDA Form 483a, FSVP Observations, was issued on August 17, 2022, but no response has been received.

The primary violation is the failure to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for any imported foods, including "covered produce" as defined in 21 CFR 112.3. For covered produce, an FSVP must demonstrate supplier compliance with processes providing public health protection equivalent to section 419 of the FD&C Act and 21 CFR part 11