FDA 483 - Cohance Lifesciences Limited - October 31, 2025

Cohance Lifesciences Ltd (DBA Chromo Labs India Private Ltd) in Hyderabad, India, a biopharmaceutical analytical facility, was cited for significant data integrity issues during an FDA inspection. The firm was observed deleting analytical instrument run data and having incomplete audit trails for method validation parameters. These findings indicate serious concerns regarding the reliability and integrity of their analytical data.