# FDA 483 - Glenmark Life Sciences Limited - July 05, 2019

Source: https://www.globalkeysolutions.net/records/483/glenmark-life-sciences-limited/50b7309f-a686-4319-896b-93444b555a0c

> FDA 483 for Glenmark Life Sciences Limited on July 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Life Sciences Limited
- Inspection Date: 2019-07-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Glenmark Life Sciences Limited in Ankleshwar, India, revealed significant deficiencies across multiple areas. Observations included inadequate personnel training and record-keeping, incomplete batch production and control records, and deficient control systems to prevent contamination. Furthermore, the firm failed to conduct comprehensive investigations into product impurities, indicating a lack of robust quality control.

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## Related Officers

- [Saied Hosseini](https://www.globalkeysolutions.net/people/saied-hosseini/861f71dd-e4e2-458a-8127-7d08339925b9)

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