# FDA WARNING_LETTER - Alfred Louie, Inc. - February 20, 2024

Source: https://www.keypedia.com/records/warning_letter/alfred-louie-inc/d621b379-b374-4b09-9d6a-1543a806b164

> FDA WARNING_LETTER for Alfred Louie, Inc. on February 20, 2024. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Alfred Louie, Inc.
- Inspection Date: 2024-02-20
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The FDA inspected a sprouting and noodle manufacturing facility at 4501 Shepard St., Bakersfield, CA, from January 2 to February 20, 2024. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117) and significant violations of food labeling regulations (21 CFR Part 101).

Key violations include:
1.  **Hazard Analysis and Preventive Controls (Subpart C):** The firm failed to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards.
    *   **Allergens:** Failed to identify and control allergens (wheat, egg) despite manufacturing products with different allergen profiles on shared, difficult-to-clean equipment. Finished product labels for Pan Fry Fresh Noodles and Deep Fry Fresh Noodles did not declare wheat, leading to a product recall.
    *   **Mycotoxins:** Failed to identify and evaluate mycotoxins (e.g., deoxynivalenol in wheat flour) as a hazard requiring a preventive control and lacked a risk-based supply-chain program for raw materials.
    *   **Metal:** Failed to identify and evaluate metal as a hazard, despite using processing equipment with metal-to-metal contact and lacking metal detectors or other controls.

2.  **Misbranding Violations:** Finished product labels were misbranded.
    *   **

## Related Officers

- [Darla R. Bracy](https://www.keypedia.com/people/darla-r-bracy/ff507c75-ede3-4915-9aea-d8971842d891)

Company: https://www.keypedia.com/companies/alfred-louie-inc/c4a09507-7ba8-47d1-8077-9469babeddb1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b