# FDA 483 - Glenmark Pharmaceuticals Limited - July 01, 2022

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/5c9b47bb-ce4e-4cf4-a78c-507c99cb05ab

> FDA 483 for Glenmark Pharmaceuticals Limited on July 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Limited
- Inspection Date: 2022-07-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/glenmark-pharmaceuticals-limited/dacc6330-129c-4ce4-8c41-f71525daebe5

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1