FDA WARNING_LETTER - Nox Bellcow Cosmetics Co. Ltd. - September 22, 2017

The FDA inspected Nox Bellcow Cosmetics Co., Ltd. from September 18-22, 2017, identifying significant CGMP violations, rendering their drug product adulterated. The company's October 22, 2017, response was deemed inadequate.

Key violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a))**: The quality unit released drug product before receiving active ingredient assay results and lacked sufficient systems for change control, quality control testing, batch record review, and annual product reviews. Required actions include a retrospective review of assay results for marketed products, a comprehensive assessment of documentation systems, and an independent assessment and remediation plan for the quality unit. 2. **Failure to Test Components (21 CFR 211.84(d)(1) and (2))**: The firm failed to perform identity tests on incoming APIs, relying on appearance/odor, and did not test for purity, strength, or validate supplier COAs. The FDA requires procedures for incoming component testing, including identity tests for all components and validation of supplier COAs. 3. **Inadequate Cleaning Procedures (21 CFR 211.67(b))**: Cleaning validation for a non-dedicated tank was inadequate, with OOS results for residual disinfectant that were not investigated. The company must assess the impact of residuals, implement a cleaning validation program,