FDA 483 - Sun Pharmaceutical Industries Limited - March 17, 2023

Sun Pharmaceutical Industries Limited in New Delhi, India, was cited during an FDA inspection of its Biopharmaceutics Clinical Facility for significant data integrity and submission issues. The firm failed to include critical addendums to clinical study reports in an abbreviated new drug application and could not provide original electronic study documentation for review due to a global information security incident. These observations indicate deficiencies in data management and regulatory submission practices.