FDA WARNING_LETTER - Torrent Pharmaceuticals Limited - April 16, 2019

The FDA inspected Torrent Pharmaceuticals Limited's drug manufacturing facility in Indrad, Gujarat, from April 8 to 16, 2019, identifying significant current good manufacturing practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the firm's failure to follow written procedures for production and process control (21 CFR 211.100(b)), specifically by circumventing process validation protocols for Losartan Potassium Tablets and releasing commercial batches despite validation failures and out-of-specification (OOS) results. Additionally, the firm failed to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192), exhibiting inadequate OOS investigations, invalidating initial failing results without scientific justification, and maintaining a high rate of invalidated OOS results. This is a repeat observation, indicating inadequate executive management oversight. The FDA deemed the firm's response to the Form FDA 483 inadequate. Torrent Pharmaceuticals is required to conduct a comprehensive global assessment, provide root cause analyses, and submit a written response within 15 working days detailing corrective actions and a completion schedule. The FDA recommended engaging a qualified CGMP consultant. Failure to comply may result in withheld drug approvals and refusal of admission for products into the U.S.