FDA WARNING_LETTER - American Chinese Natural Herbs, Inc. - March 17, 2022

On February 10, 2023, the FDA issued a Warning Letter to Dr. Duong following an inspection of their Garland, TX facility from February 15, 2022, to March 17, 2022. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act, specifically regarding Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. **Failure to establish component specifications (21 CFR 111.70(b))**: No specifications were established for ingredients like Thorough Wax Extract, American Ginseng Extract, and Oyster Extract. The firm's response was inadequate, lacking documentation of established specifications. 2. **Failure to establish finished product specifications (21 CFR 111.70(e))**: Product "specification sheets" only listed ingredients and weights, lacking details for identity, purity, strength, and composition. The proposed use of organoleptic attributes was deemed insufficient. 3. **Failure to establish complete Master Manufacturing Records (MMRs) (21 CFR 111.210)**: MMRs for products like Stomach Miracle and Almond Plus lacked required information such as dietary ingredient strength, complete component lists, accurate weights, declared ingredients, intentional overage, packaging descriptions, representative labels, and detailed written instructions