# FDA WARNING_LETTER - Wan-Gee Foods, Inc. - May 24, 2023

Source: https://www.keypedia.com/records/warning_letter/wan-gee-foods-inc/23d4a6ba-fa2c-4d81-a977-0258b01dfdb0

> FDA WARNING_LETTER for Wan-Gee Foods, Inc. on May 24, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Wan-Gee Foods, Inc.
- Inspection Date: 2023-05-24
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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

## Related Officers

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

Company: https://www.keypedia.com/companies/wan-gee-foods-inc/ad71621c-8d4e-41bf-ba8a-0ee1036ac7f3

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