FDA WARNING_LETTER - Manzela USA, LLC - June 24, 2022

On November 7, 2022, the FDA issued a Warning Letter to Manzela USA, LLC, following a Foreign Supplier Verification Program (FSVP) inspection from June 15-24, 2022, and a previous inspection on May 13, 2020. The inspections found significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, regarding imported human and/or animal food.

The company failed to develop, maintain, and follow an FSVP for imported foods, as required by 21 CFR 1.502(a). Specifically, they did not evaluate foreign supplier performance or the risk posed by the food, nor did they approve foreign suppliers based on such evaluations, violating 21 CFR 1.505. A provided "Food Safety Plan, Manzela USA" for Haba Enchilada from Manzela, S.A. De C.V., Mexico, lacked details on who would conduct activities, how information related to foreign supplier performance, and did not include the required evaluation or approval.

Furthermore, Manzela USA, LLC did not perform foreign supplier verification activities in accordance with 21 CFR 1.506. They failed to document the determination or performance of appropriate supplier verification activities for Haba Enchilada, establish written procedures for these activities, or document the