FDA 483 - Mexi-Land Inc. - April 29, 2024

From April 23-29, 2024, the FDA inspected Mexi-Land Inc. in City of Industry, CA, focusing on their Foreign Supplier Verification Program (FSVP). The inspection, led by Investigator John R Myung, identified eight observations regarding the company's compliance.

Key violations include the absence of a written hazard analysis for imported Tamarind Flavored Soft Candy and a deficient hazard analysis for ENCHILOKAS JOVY MANGO 24/480G GOMAS, which failed to identify Tartrazine, peanut, wheat flour, and soy as potential allergens. Additionally, product label ingredient lists did not consistently match internal documentation.

Mexi-Land Inc. also failed to document evaluations or reviews of foreign supplier performance, specifically for the ENCHILOKAS JOVY MANGO product, where the evaluation did not consider Preventive Controls for Human Foods. Supplier approval documentation was missing for Tamarind Flavored Soft Candy, and approvals for ENCHILOKAS JOVY MANGO were signed by an employee of the foreign supplier.

Further deficiencies included the lack of documented reevaluation of foreign suppliers within the required three-year period and the absence of written procedures to ensure imports only from approved foreign suppliers. Onsite audits of foreign suppliers did not adequately cover FDA's Preventive Controls for Human Foods regulation, and the frequency of verification activities for imported foods was not determined or documented. The Purchasing Director, Cristina Candelario, was issued