FDA 483 - Sun Pharmaceutical Industries Ltd. - June 11, 2019

This FDA Form 483 details significant deficiencies at Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, observed during a June 2019 inspection. The firm failed to follow procedures for sterile drug product manufacturing, maintain proper laboratory control documentation, adequately establish design plans for a medical device, and validate a critical assembly process. These issues indicate a lack of robust quality control and process validation.