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

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. * **