FDA WARNING_LETTER - JX Restaurants, Inc. - September 01, 2023

The FDA inspected a ready-to-eat (RTE) rice and noodle-based meals manufacturing facility in Maryland Heights, MO, from August 8 to September 1, 2023. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117). Environmental samples confirmed the presence of *Listeria monocytogenes*, rendering products adulterated.

Key violations include: 1. **Inadequate Hazard Analysis and Preventive Controls:** The facility failed to identify recontamination with environmental pathogens (e.g., *L. monocytogenes*) and allergen cross-contact as hazards requiring preventive controls, despite *L. monocytogenes* being found in the facility and observed allergen cross-contact. 2. **Failure to Evaluate Hazards:** The facility did not evaluate bacterial pathogens in RTE ingredients (e.g., noodles) that receive no kill-step, nor mycotoxins in wheat flour and peanuts, as hazards requiring preventive controls or supply-chain programs. 3. **Ineffective Preventive Controls:** The firm did not adequately implement controls for bacterial growth/toxin formation during chilling, lacking proper records and procedures. 4. **CGMP Violations:** Observed issues included employees not washing hands, unsanitary plant conditions (cracked floors, *Listeria* spp. presence), improper cleaning/sanitation (use of high