# FDA 483 - Glenmark Life Sciences Limited - January 27, 2025

Source: https://www.globalkeysolutions.net/records/483/glenmark-life-sciences-limited/1b835108-bcc1-4085-954e-8612b345f7b7

> FDA 483 for Glenmark Life Sciences Limited on January 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Life Sciences Limited
- Inspection Date: 2025-01-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Granules Life Sciences Limited, an API manufacturer in Ankleshwar, Gujarat, was cited for failing to prevent contamination during production operations. Inspectors observed magnetic metal fragments in equipment after cleaning hold times expired, and the firm had received multiple market complaints regarding metal foreign material. This indicates a significant issue with contamination control and equipment cleaning procedures.

## Related Documents

- [483 - 2019-07-05](https://www.globalkeysolutions.net/records/483/glenmark-life-sciences-limited/50b7309f-a686-4319-896b-93444b555a0c)

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/glenmark-life-sciences-limited/7932bbbd-18cb-46ff-84bf-cf62c7f6c44a

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