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

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.