FDA WARNING_LETTER - Glenmark Pharmaceuticals Limited - May 20, 2022

The FDA inspected Glenmark Pharmaceuticals Limited in Goa, India, from May 12-20, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's June 12, 2022, response to the Form FDA 483 was deemed inadequate. Key violations include the failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192), specifically regarding desmopressin acetate tablets, leading to a voluntary recall. The firm also failed to establish adequate written procedures for production and process control (21 CFR 211.100(a)), evidenced by inadequate process validation for (b)(4) gel (b)(4)% and subsequent viscosity-related rejections. Furthermore, the company failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)), including issues with chromatographic peak integration, manual data modification without controls, and incorrect minimum area calculations. Finally, batch production and control records were incomplete (21 CFR 211.188), lacking batch-specific data for compression machine reject limits. The FDA requires a written response within 15 working days detailing corrective actions and prevention measures, emphasizing that these are not an all-inclusive list of violations.