FDA WARNING_LETTER - Santa Cruz Produce, Inc. - November 14, 2022

On November 14, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Sana Cruz Produce, Inc., located at 30 Old Tucson Rd Ste 3, Nogales, AZ. This followed a previous inspection from August 9-24, 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and the FSVP regulation (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 inspection revealed the firm is not in compliance with 21 CFR part 1, subpart L, constituting a significant violation of section 805 of the FD&C Act. Specifically, Sana Cruz Produce, Inc. failed to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a) for any imported foods, including Fresh Mango and Fresh Kabocha Squash from specified foreign suppliers.

An FDA 483a FSVP Observations form was issued on November 14, 2022, but no response has 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, potentially leading to detention without physical examination (DWPE) under Import Alert #