483
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited – FDA 483, Jul 1, 2022
Record Details
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.
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ID · 5c9b47bb-ce4e-4cf4-a78c-507c99cb05ab
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