# FDA 483 - Eurofins Biopharma Product Testing India Private Ltd. - June 20, 2025

Source: https://www.keypedia.com/records/483/eurofins-biopharma-product-testing-india-private-ltd/112b21b9-d14d-4a4e-bfa8-1353ab82305a

> FDA 483 for Eurofins Biopharma Product Testing India Private Ltd. on June 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Biopharma Product Testing India Private Ltd.
- Inspection Date: 2025-06-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: This FDA Form 483 was issued to Eurofins Biopharmaceutical Product Testing India Pvt Ltd in Bengaluru, India, following an inspection. The report details significant deficiencies in the firm's Quality Control Unit, including failures in data integrity, inadequate standard operating procedures, and insufficient investigations into out-of-specification results. The observations indicate a lack of robust laboratory controls, method validation, and employee training, posing potential risks to the quality and integrity of drug product testing.

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/eurofins-biopharma-product-testing-india-private-ltd/3bf38a57-43cd-47f1-bade-72b277baf1e7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8