FDA WARNING_LETTER - Mexi-Land Inc. - July 29, 2020

On November 24, 2020, the FDA issued a Warning Letter to Mexi-Land Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from July 20-29, 2020. This inspection, along with a previous one on August 16, 2017, aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The FDA found Mexi-Land Inc. non-compliant with FSVP requirements for imported food products, including soft candy tamarind flavor, chocolate covered marshmallow lollipops, and Enchilokas mango soft candy, all from Mexico. Despite a response dated August 4, 2020, stating a consultant was hired to develop an FSVP within 30 business days, no additional records were received.

Significant violations include: 1. Failure to document review and assessment of foreign supplier hazard analyses (21 CFR 1.504(d)). 2. Failure to approve foreign suppliers based on performance and risk evaluation, and to document this approval (21 CFR 1.505(a), (b)). 3. Failure to establish and follow written procedures for importing only from approved foreign suppliers (21 CFR 1.506(a)(1)). 4. Failure to determine and document required verification