# FDA 483 - Strides Pharma Science Limited - May 24, 2019

Source: https://www.globalkeysolutions.net/records/483/strides-pharma-science-limited/6aba0508-6d58-45c8-abe2-72447d775be9

> FDA 483 for Strides Pharma Science Limited on May 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strides Pharma Science Limited
- Inspection Date: 2019-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Strides Pharma Science Limited in Bangalore, Karnataka, India, a manufacturer of finished drugs, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to conduct complete investigations into out-of-specification results and unexplained discrepancies, and lacked adequate control procedures for monitoring manufacturing processes and environmental conditions. Additionally, laboratory controls for media acceptance were found to be deficient.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/strides-pharma-science-limited/fbdc3ce9-e3c5-4667-86ce-77b376a00100

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