# FDA 483 - BIONEEDS INDIA PRIVATE LIMITED - January 19, 2024

Source: https://www.keypedia.com/records/483/bioneeds-india-private-limited/4e96a32a-472c-49d8-ae6e-f8b1c3b38a8a

> FDA 483 for BIONEEDS INDIA PRIVATE LIMITED on January 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIONEEDS INDIA PRIVATE LIMITED
- Inspection Date: 2024-01-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Bioneeds India Private Limited, a contract testing laboratory in Bangalore Rural, India, was cited for significant deficiencies in its laboratory control systems during an FDA inspection. Observations included inadequate evaluation of method validation deviations, insufficient procedures for investigating assay failures, and a failure to consistently follow validated test methods. These issues indicate a lack of robust quality control over drug substance and drug product testing.

## Related Officers

- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/bioneeds-india-private-limited/961c566d-eff4-4542-95ca-2f9fe23d5c56

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