FDA WARNING_LETTER - Blaine Labs Inc - September 30, 2019

The FDA inspected Blaine Labs Inc. from September 25-30, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm also manufactures "RevitaDERM PSORIASIS Treatment," an unapproved new drug.

Key violations include: 1. **Inadequate OOS Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate OOS results for products like Terpenicol AFC 13% topical cream (viscosity), Tineacide Antifungal Cream 13% (stability, appearance, viscosity, assay), and a raw material (microbial contamination), leading to release of affected lots. A retrospective review of all invalidated OOS results and a comprehensive assessment of the investigation system are required. 2. **Lack of Process and Cleaning Validation (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for multiple drug products, qualify equipment, and validate cleaning processes. A detailed validation program, timeline for PPQ, and improved cleaning validation program are required. 3. **Inadequate Water System Monitoring (21 CFR 211.84(d)(6)):** The firm did not adequately monitor or validate its water system, which supplied water for drug products and equipment cleaning. A comprehensive remediation plan for the water system and a procedure for ongoing control are required. 4