FDA WARNING_LETTER - Dae Young Foods Co., Ltd. - March 17, 2017

The FDA inspected Dae Young Foods Co., Ltd.'s drug manufacturing facility from March 13-17, 2017, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, their "Smoker's Appetite Relief" product was deemed misbranded under 21 U.S.C. 352(a).

Key violations include: 1. **Failure to visually examine components:** The firm accepted an in-process component with multiple active ingredients, including potentially toxic Nux vomica (containing strychnine), without proper labeling or matching batch numbers, violating 21 CFR 211.82(a). 2. **Failure to test components:** The firm did not test incoming drug components for identity, purity, strength, or quality, nor did they establish the reliability of supplier certificates of analysis, violating 21 CFR 211.84(d)(1) & (2). 3. **Inadequate Quality Control Unit:** The firm lacked an adequate quality control unit, failing to establish written procedures for functions like complaints, deviations, investigations, and other basic manufacturing operations. They also lacked documentation for change control, annual product reviews, and batch record review/approval, violating 21 CFR 211.22(a