FDA 483 - Glenmark Pharmaceuticals Ltd - February 14, 2025

During an inspection conducted from February 3 to February 14, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Glenmark Pharmaceuticals Ltd. at its Pithampur, Madhya Pradesh, India facility. The inspection revealed significant deficiencies in the firm's manufacturing processes and quality control systems, indicating potential non-compliance with current Good Manufacturing Practices (cGMP) regulations.

Key observations highlighted critical issues in contamination control and product quality. The FDA noted inadequate cleaning procedures for shared equipment, leading to drug product residue carryover and instances where residue levels exceeded acceptable limits. Cleaning validation studies were found insufficient, and the facility lacked robust measures to prevent cross-contamination, including shared personnel, equipment, and air handling systems without proper verification. This raised concerns about the purity of drug products, particularly those shipped to the U.S.

Furthermore, the inspection identified a failure to thoroughly investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results for dissolution tests, with multiple instances lacking adequately supported root causes or appropriate corrective actions before product release. Analytical test methods for numerous commercial drug products and Active Pharmaceutical Ingredients (APIs) were found to be unvalidated or improperly verified for critical parameters like accuracy and specificity. Finally, the quality control unit was cited for significant delays, ranging from one to twelve months, in completing stability studies for commercial samples, potentially resulting in products being distributed without adequate supporting stability data.

Glenmark Pharmaceuticals is expected to provide a comprehensive response detailing corrective and preventive actions to address these serious observations and ensure compliance with regulatory standards for drug manufacturing.