FDA 483 - Glenmark Pharmaceuticals Ltd - February 14, 2025

This FDA Form 483, issued to Umesh Gupta, Senior VP & Site Head of Glenmark Pharmaceuticals Ltd. in Pithampur, Madhya Pradesh, India (FEI 3008565058), details observations from an inspection conducted from February 3-14, 2025. The facility is a drug manufacturer.

**Key Observations:**

1. **Inadequate Equipment Cleaning and Contamination Control:** * Failure to prevent cross-contamination of drug products manufactured on non-dedicated equipment, specifically with (b)(4) drug product residues. * Approximately (b)(4) incidents since (b)(4) of detected (b)(4) carryover residue exceeding (b)(4) ppm after cleaning, impacting (b)(4) batches, including (b)(4) shipped to the US. * Inadequate cleaning validation studies for (b)(4) Tablets, failing to consider the unique nature of (b)(4) drugs and contamination risk. * No routine monitoring of (b)(4) residue before (b)(4), leading to (b)(4) impacted batches shipped to the US. * Lack of decontamination agents for equipment used in (b)(4) drug products before manufacturing (b)(4) drug products. * Personnel entry/exit procedures allow operators to work in both (b)(6) and (