Colgin, Inc. – FDA Warning Letter, Sep 21, 2023

The FDA issued a Warning Letter to Colgin, Inc. (FEI 1610391) on January 25, 2024, following an inspection from September 18 to September 21, 2023, at their Dallas, TX drug manufacturing facility. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals, rendering their drug product, ChigaRid External Analgesic, adulterated.

Key violations include: 1. **Failure to test components for identity and validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)):** Colgin, Inc. did not adequately test incoming components for identity and relied on supplier Certificates of Analysis (COA) without establishing their reliability. Additionally, expired raw materials were approved for use. The firm's response was inadequate due to lack of documentation, retrospective evaluation, and clear timelines. 2. **Failure to establish written procedures for production and process control (21 CFR 211.100(a)):** The firm has not validated its manufacturing processes for ChigaRid External Analgesic. Their response was inadequate due to lack of documentation, retrospective impact assessment, clear timelines, and interim production plans. 3. **Quality