Cohance Lifesciences Limited – FDA 483, Aug 12, 2025

The FDA conducted an inspection of Cohance Lifesciences Limited, a finished drug product manufacturer located in Secunderabad, Telangana, India, from August 4 to August 12, 2025. The inspection revealed significant compliance issues primarily related to the company's quality system. Key observations included the failure to thoroughly review and document discrepancies and batch failures. Specifically, there was no documentation on the disposition of a rejected batch of tablets, which had not been disposed of 23 months after the decision to destroy it was made. Additionally, there were gaps in addressing out-of-specification (OOS) results and implementing preventive actions for manufacturing and packaging processes.

The inspection also identified a lack of documentation for extractable and leachable studies for packaging materials used for products distributed to the U.S. market. Furthermore, the firm failed to maintain complete records of drug complaint investigations, as evidenced by missing follow-up documentation for a specific complaint.

The FDA's observations highlight the need for Cohance Lifesciences Limited to enhance its quality assurance processes, ensure thorough documentation of discrepancies and corrective actions, and maintain comprehensive records of all investigations and studies related to product safety and compliance. The company is expected to address these issues promptly to align with regulatory requirements and ensure the integrity of its products.