Generitech Corporation – FDA Warning Letter, Jul 28, 2021

The FDA issued a Warning Letter to Generitech Corporation following an inspection from July 6-28, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. Additionally, (b)(4) Hydroquinone Cream and (b)(4) were cited as unapproved new drugs and misbranded.

Key violations include: 1. **Failure to investigate unexplained discrepancies or OOS results (21 CFR 211.192):** The firm failed to investigate OOS assay results for topical OTC drug products, such as salicylic acid in (b)(4) drug product Lot (b)(4), which tested outside specifications. The firm's response regarding lack of resources and personnel was deemed inadequate. 2. **Failure to test components for identity and conformity, and validate supplier analyses (21 CFR 211.84(d)(1) and (2)):** The firm did not perform identity testing for each component lot, including salicylic acid, and failed to establish the reliability of supplier Certificates of Analysis (COAs). This was a repeat observation from a 2013 inspection. 3. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm did not appropriately validate processes or qualify equipment for topical OTC drug products, lacking process performance qualification (PPQ) studies