FDA WARNING_LETTER - Glenmark Pharmaceuticals Limited - April 20, 2019

The FDA issued a Warning Letter to Glenmark Pharmaceuticals Limited following an inspection from April 15-20, 2019, at their Baddi Solan, Himachal Pradesh facility. The letter cites significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** * Inadequate investigation of multiple grittiness complaints for topical (b)(4) cream USP, (b)(4)%, an ongoing issue since 2010. The firm's proposed reformulation and recall were not timely, and data supporting the new formulation's robustness was insufficient. * Failure to adequately investigate multiple temperature excursions during shipping of drug products, including (b)(4) cream USP and (b)(4) USP, leading to distribution of products exposed to temperatures outside labeled conditions. Risk assessment for marketed batches was inadequate, and new shipping practices were not timely. * Inadequate investigation of multiple Out-of-Specification (OOS) test results for critical product attributes like (b)(4) and (b)(4), failing to determine root causes or ensure effective CAPA. * Failure to adequately investigate over 70 consumer complaints regarding punctures, cracks, and holes in (