# FDA 483 - MSN Life Sciences Private Limited - June 03, 2022

Source: https://www.keypedia.com/records/483/msn-life-sciences-private-limited/53c6805c-7e95-4be7-89e8-4a4401c2debe

> FDA 483 for MSN Life Sciences Private Limited on June 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSN Life Sciences Private Limited
- Inspection Date: 2022-06-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: MSN Life Sciences Private Limited, an Active Pharmaceutical Ingredient Manufacturer in Kamareddy, India, was cited with three observations during an FDA inspection. The inspection revealed significant deficiencies in data integrity, including inadequate audit trail review for analytical data, and issues with quality control, such as unscientific water sampling plans for microbial analysis and unvalidated analytical and cleaning methods. These findings indicate a lack of robust quality systems for ensuring product quality and data reliability.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.keypedia.com/companies/msn-life-sciences-private-limited/f2cf20e5-159c-4ca8-9da6-e272af4a142c

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