FDA WARNING_LETTER - Lucero Produce II Corp. - July 22, 2022

On October 26, 2022, the FDA issued a Warning Letter to Lucero Produce II Corp. following a Foreign Supplier Verification Program (FSVP) inspection from July 12-22, 2022. Previous inspections occurred on August 28, 2018, and January 4-20, 2021. The inspection found the company not in compliance 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 significant violation identified 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).

The FDA acknowledged an August 9, 2022, response from Lucero Produce II Corp. requesting more time, but no further documentation was received to demonstrate corrective actions. 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, placement on detention