FDA 483 - Sun Pharmaceutical Medicare Limited - July 13, 2023

An FDA inspection of Sun Pharmaceutical Medicare Limited, a sterile drug manufacturer in Halol, India, revealed significant deficiencies in their quality control laboratory. The firm failed to adequately investigate numerous "Unsuccessful Logon Attempt" messages in their Empower software audit trail, which is used for drug product testing. This lack of investigation raises concerns about data integrity and unauthorized access to analytical raw data.