ng zheng inc. – FDA Warning Letter, Oct 23, 2023

On April 23, 2024, the FDA issued a Warning Letter to Mr. Zheng following an inspection of his manufacturing facility at 1140 W Louisiana Avenue, Denver, Colorado, from September 18 to October 23, 2023. The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

The facility's ready-to-eat (RTE) egg, flour, and fried noodle products, and not-ready-to-eat (NRTE) wonton, egg roll, and dumpling wrapper products were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. The firm also failed to register its facility as required by section 415 of the Act, a prohibited act under section 301(dd).

Key violations included: 1. **Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):** * Failure to conduct a hazard analysis for undeclared allergens (wheat, egg) in NRTE products, leading to distribution of unlabeled products. * Failure to implement preventive control procedures for allergen cross-contact, evidenced by egg dough residue on shared equipment after cleaning and lack