FDA WARNING_LETTER - Jubilant Generics Limited - August 08, 2018

The FDA issued a Warning Letter to Jubilant Generics Limited following an inspection of their Roorkee, India drug manufacturing facility from July 30 to August 8, 2018. 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. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate discrepancies, such as a particle size issue with crospovidone excipient affecting multiple drug products. An investigation (PR 8065) identified a mislabeled drum, but the firm discarded other drums from the same shipment, preventing confirmation. Ten affected valsartan tablet batches were not recalled promptly. Additionally, investigations into numerous complaints for damaged pantoprazole delayed-release tablets (batch PA26037A) were insufficient in timeliness and depth, failing to perform dissolution testing on severely damaged samples. The firm's response was inadequate, lacking a retrospective review of investigation processes, root cause analysis competencies, timeliness, and CAPA effectiveness. 2. **Failure to Test and Reject In-Process Materials (21 CFR 211.110(c)):** The quality control unit failed to follow established process controls for (b)(4) tablets. Despite a change control (CC/1