FDA WARNING_LETTER - Hanbul Cosmetics Co., Ltd - December 01, 2017

On March 29, 2018, the FDA issued a Warning Letter to Hanbul Cosmetics Co., Ltd. following an inspection from November 27 to December 1, 2017. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations included: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm lacked raw data to verify microbiological finished product testing for OTC drug products. 2. **Inadequate Stability Testing Program (21 CFR 211.166(a)):** Stability studies were insufficient to support labeled expiry periods, relying only on six-week accelerated studies without long-term data. The program also lacked active ingredient assay determination, testing methodology, frequency, and container/closure system information. 3. **Incomplete Batch Production and Control Records (21 CFR 211.188):** Batch records omitted critical details such as raw material weights, process start/stop times, signatures for significant steps, and copies of finished product labeling. 4. **Unqualified Equipment (21 CFR 211.63):** Equipment used in production, packaging, and release testing for OTC drug products was not