La Sonorense, Inc. – FDA Warning Letter, Mar 21, 2020

The FDA issued a Warning Letter to a ready-to-eat (RTE) corn and flour tortilla manufacturer in Phoenix, Arizona, following an inspection from March 16-21, 2020. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), rendering the food adulterated.

Key violations include: 1. **Lack of Hazard Analysis:** The firm failed to identify and evaluate known or foreseeable hazards, including undeclared allergens (wheat), bacterial pathogens (E. coli, Salmonella, Listeria monocytogenes in flour), environmental pathogens (Salmonella post-(b)(4) step), and mycotoxins in wheat and corn flour. A voluntary recall of bulk Pressed Wheat Flour Tortillas occurred due to undeclared wheat. 2. **No Preventive Controls:** The firm did not identify and implement preventive controls for any products to minimize or prevent hazards, including process, food allergen, sanitation, supply-chain controls, and a recall plan. 3. **Missing Food Safety Plan:** A written food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring, corrective action, and verification procedures, was not prepared or implemented. 4. **Pest Exclusion Failure:** Open dock doors, a non-functioning air curtain, and gaps allowed pests. Rodent excreta