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Talk to a SpecialistTalk to a SpecialistWan-Gee Foods, Inc. was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations during an FDA inspection of its not-ready-to-eat noodle products facility in St. Louis, Missouri conducted in May 2023. The company failed to identify and evaluate known hazards such as bacterial growth and toxin formation due to inadequate time/temperature controls for products including wonton wrappers, egg roll wrappers, and noodles, and did not implement required preventive controls under 21 CFR Part 117. The facility's nRTE noodle products were determined to be adulterated as they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. The company had not responded to the FDA Form 483 observations issued at the conclusion of the inspection.