Wan-Gee Foods, Inc. – FDA Warning Letter, May 24, 2023

On November 9, 2023, the FDA issued a Warning Letter to a manufacturing facility located at 10849 Midwest Industrial Blvd. St. Louis, MO 63132, following an inspection from May 2 to 24, 2023. The inspection focused on the facility's not ready-to-eat (nRTE) noodle products manufacturing operation.

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), deeming the nRTE noodle products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The facility failed to provide a response to the FDA Form 483 issued at the inspection's conclusion.

Key violations include: - **Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):** - Failure to identify and evaluate bacterial growth/toxin formation due to lack of time/temperature control for noodle products during production and finished product storage (canton noodles), specifically concerning *Staphylococcus aureus* and water activity. - Failure to identify and evaluate mycotoxins (e.g., deoxynivalenol) in wheat flour as a hazard requiring a supply-chain preventive control. - Failure to