Glenmark Pharmaceuticals LimitedJuly 1, 2022

FDA 483 - Glenmark Pharmaceuticals Limited - July 01, 2022

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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.

Company: Glenmark Pharmaceuticals Limited
Inspection Date: July 1, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Rajiv R. Srivastava (Consumer Safety Officer)

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ID · 5c9b47bb-ce4e-4cf4-a78c-507c99cb05ab