# FDA 483 - Strides Pharma Science Limited - Unknown Date

Source: https://www.keypedia.com/records/483/strides-pharma-science-limited/90c2d56c-27fb-4049-ab51-87f0a4bd395c

> FDA 483 for Strides Pharma Science Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strides Pharma Science Limited
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Strides Pharma Science Ltd. in Bangalore, India, received a Form 483 with five observations during an FDA inspection. The firm was cited for significant deficiencies in laboratory controls, including unvalidated microbial identification methods and data integrity issues with chromatography systems. Other major findings included failure to retain electronic audit trail data, inadequate equipment cleaning practices leading to potential cross-contamination, and insufficient controls over computerized manufacturing recipes and component testing.

## Related Documents

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- [483 - 2019-05-24](https://www.keypedia.com/records/483/strides-pharma-science-limited/6aba0508-6d58-45c8-abe2-72447d775be9)
- [WARNING_LETTER - 2019-02-05](https://www.keypedia.com/records/warning_letter/strides-pharma-science-limited/9094bd0f-e795-485b-8e95-4d89c54fc2a4)
- [483 - 2022-12-05](https://www.keypedia.com/records/483/strides-pharma-science-limited/f5252c0a-3939-479b-bf6e-303e700b5a1c)
- [483 - 2026-05-20](https://www.keypedia.com/records/483/strides-pharma-science-limited/eeacb2ba-12ef-447b-8b96-f04711c33a81)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Constance L. Richard Math](https://www.keypedia.com/people/constance-l-richard-math/9a61f4c9-62ba-4b09-b843-968d9d394b6f)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3