FDA 483 - Glenmark Pharmaceuticals Limited - July 01, 2022

Glenmark Pharmaceuticals Limited, a drug product manufacturer in Aurangabad, India, was cited for failing to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. The inspection revealed an instance where initial OOS results for a stability assay were invalidated based on an inconclusive investigation into a "sample preparation error." This indicates a significant lapse in quality control and investigation procedures.