FDA WARNING_LETTER - Lucky K.T. Co., Inc. - May 11, 2023

The FDA inspected a food manufacturing facility at 10925 Schmidt Rd, El Monte, CA, from April 18 to May 11, 2023, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (21 CFR Part 117), and labeling regulations (21 CFR Part 101).

The facility's noodle products (Fresh Rice Noodle, Rice Stick Noodle, Egg Noodle, Chow Mein Noodle, and Pancit Noodle) were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions and misbranded under 21 U.S.C. § 343.

Key violations include: 1. **Lack of a Food Safety Plan:** No food safety plan, hazard analysis, or preventive controls for bacterial pathogens (e.g., *Bacillus cereus*, *Clostridium botulinum*), allergens, or mycotoxins. 2. **CGMP Violations:** * **Hygienic Practices:** Employees handled food with bare hands after breaks, touched ears, wore jewelry, and stored personal items (cell phones, watches, rings) near food. * **Equipment and Utensils:** Equipment was not adequately cleanable or maintained (e.g., noodles