FDA WARNING_LETTER - Kanebo Cosmetics Inc. - September 06, 2012

On April 1, 2013, the FDA issued a Warning Letter to Kanebo Cosmetics Inc. following an inspection from September 3-6, 2012, at their Odawara, Japan facility. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Lack of Finished Product Testing (21 CFR 211.165(a))**: The firm failed to determine the purity and strength of active ingredients in OTC drug products manufactured before June 2012, which are currently in the U.S. market. The FDA requires scientifically sound test procedures, sampling plans, specifications, validation documentation for non-compendial methods, and test results for all U.S.-distributed batches within expiry. 2. **Inadequate Stability Testing Program (21 CFR 211.166(a))**: Accelerated stability studies lacked active ingredient purity/strength assays, and long-term studies for U.S.-distributed OTC products were not conducted. The firm must provide an action plan for affected batches, documentation supporting expiration dates, and assurance of a robust, validated stability program. 3. **Failure to Test Components (21 CFR 211.84(d)(2))**: The firm