FDA 483 - Unexo Life Sciences Private Limited - May 14, 2024

This 483 report for Unexo Life Sciences, Private Limited, details severe data integrity deficiencies, inadequate quality control unit oversight, and a lack of thorough investigations into adverse events. The inspection revealed significant issues with record-keeping, method validation, computer system controls, equipment maintenance, and process validation, indicating a systemic failure to ensure the quality and safety of drug products. These findings highlight a critical breakdown in cGMP compliance across multiple operational areas.