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

Source: https://www.globalkeysolutions.net/records/warning_letter/jx-restaurants-inc/ae01776f-dae7-4662-b2d8-4068ba6756ab

> FDA WARNING_LETTER for JX Restaurants, Inc. on September 01, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: JX Restaurants, Inc.
- Inspection Date: 2023-09-01
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.globalkeysolutions.net/companies/jx-restaurants-inc/9f8fc839-df9a-4518-b6df-4624f08ed606

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8