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Colgin, Inc. received a warning for manufacturing deficiencies in its OTC drug product ChigaRid External Analgesic that violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company failed to conduct required identity testing on incoming drug components before use, did not validate the reliability of its suppliers' test analyses at appropriate intervals, and approved expired raw materials for production. The FDA found Colgin's response inadequate because it lacked supporting documentation, did not include a retrospective evaluation of potentially affected products already on the market, and provided unclear completion timelines for corrective actions.