FDA WARNING_LETTER - Episciences Inc - March 11, 2022

The FDA inspected Episciences Inc. in Boise, ID, from March 7-11, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's response to the FDA 483 was deemed inadequate. Key violations include the failure to thoroughly investigate out-of-specification (OOS) laboratory results with scientifically supported conclusions and corrective actions (21 CFR 211.192). The firm also failed to establish and follow adequate written procedures for production and process control, specifically lacking proper validation for OTC drug manufacturing processes (21 CFR 211.100(a) & 211.100(b)). Furthermore, Episciences did not perform appropriate laboratory determination of satisfactory conformance to final specifications, including identity, strength, and microbiological testing, for each drug product batch prior to release (21 CFR 211.165(a) & 211.165(b)), a repeat observation. Lastly, the firm failed to conduct identity testing for each component lot and adequately establish supplier reliability (21 CFR 211.84(d)(1) & 211.84(d)(2)). The FDA strongly recommended engaging a CGMP consultant. The firm must respond within 15 working days with a detailed plan for corrective actions and recurrence prevention, or face potential regulatory actions like seizure, injunction, and withholding of export certificates or new application approvals.