Goran Pharma Pvt Ltd – FDA Warning Letter, Nov 15, 2017

The FDA issued a Warning Letter to Goran Pharma Private Limited following a November 13-15, 2017 inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to ensure component identity (21 CFR 211.84(d)(1) and (2)):** The firm relied on supplier Certificates of Analysis (COA) without adequate validation, specifically failing to test glycerin for diethylene glycol (DEG) or ethylene glycol (EG). The FDA deemed their response inadequate, requiring detailed plans for component testing, supplier COA qualification, retrospective DEG/EG testing of U.S.-distributed products, and an independent review of laboratory practices. 2. **Inadequate quality control unit (21 CFR 211.22(a)):** The quality unit released batches, including one shipped, before completing all microbiological testing. The firm's revised SOP still allowed product transfer to shipping agents prior to full testing, indicating potential distribution before final quality unit review. The FDA demands updated procedures ensuring complete record review before batch disposition and a CAPA for an adequately resourced quality unit. 3. **Inappropriate equipment design (21 CFR 211.63):** The firm's water system had dead legs, fostering biofilm development, and microbiology laboratory deficiencies cast doubt on bioburden detection. The firm's response regarding