FDA WARNING_LETTER - Dextrum Laboratories Inc. - July 18, 2023

The FDA issued a Warning Letter to Dextrum Laboratories Inc. following an inspection from July 10-18, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1)):** The firm, a contract manufacturer of OTC cough and cold products, did not adequately test each component lot, including active pharmaceutical ingredients like dextromethorphan, and high-risk components like glycerin, for identity and hazardous impurities such as diethylene glycol (DEG) or ethylene glycol (EG). Their response, proposing periodic third-party testing, was deemed inadequate as it lacked commitment to testing each lot and a retrospective review of previously used materials. 2. **Failure to conduct microbiological testing of components with potential for objectionable contamination (21 CFR 211.84(d)(6)):** The firm failed to adequately monitor the microbiological quality of their (b)(4) water used in manufacturing, only testing on a (b)(4) basis, despite identifying dead legs in their water system. 3. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm did not adequately validate production and process controls for their OTC drug products,