# FDA 483 - Kemwell Biopharma Private Limited - May 12, 2025

Source: https://www.keypedia.com/records/483/kemwell-biopharma-private-limited/0aee6d23-b38d-47e1-b335-5ca41af19aff

> FDA 483 for Kemwell Biopharma Private Limited on May 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kemwell Biopharma Private Limited
- Inspection Date: 2025-05-12
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Kemwell Biopharma Private Ltd in Bengaluru, India, a contract manufacturer of human drugs, revealed significant deficiencies in quality control and sterility assurance. Observations included a lack of established acceptance criteria for visual inspection, inadequate audit trail review procedures, and critical failures in aseptic processing controls. These issues pose a high risk of microbiological contamination and compromise product sterility.

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/kemwell-biopharma-private-limited/d74ce538-0785-4ba4-8531-589e28be6f7d

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