FDA 483 - Cohance Lifesciences Limited - March 07, 2025

During an inspection conducted from March 3 to March 7, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Cohance Lifesciences Limited API Unit-IV in Hyderabad, India. The inspection identified significant deviations from current Good Manufacturing Practice (cGMP) regulations for active pharmaceutical ingredient manufacturing.

Key observations included a failure to adequately investigate and trend laboratory Out-of-Specification (OOS) results and laboratory incident reports (LIRs). Specifically, 440 LIRs since January 2022, many related to instrument or human error, lacked proper root cause analysis and effective corrective actions. An OOS investigation was also deemed deficient due to unverified data and lack of system precision.

Furthermore, analytical methods were found to be inappropriately validated. Deficiencies were noted in cleaning method validations, including insufficient recovery studies and lack of supporting raw data, as well as in methods used for product release, such as inadequate linearity and accuracy ranges for HPLC related substance tests. The company released numerous batches of products using these deficiently validated methods.

Other issues included deficient equipment qualification for a critical reactor and a lack of adherence to quality unit responsibilities, evidenced by discrepancies in method validation documentation and improper handling of laboratory incident report closures. Cohance Lifesciences Limited is required to respond to the FDA 483 by detailing comprehensive corrective and preventive actions to address these observations and ensure cGMP compliance.