FDA 483 - Sun Pharmaceutical Industries Ltd. - November 08, 2019

Sun Pharmaceutical Industries Ltd. in Baruch, Gujarat, India, received a Form 483 for significant deficiencies in their API manufacturing operations. Observations included inadequate written procedures for testing leading to potential data integrity issues, insufficient investigation and documentation of Out-of-Specification results, and incomplete investigations of quality-related complaints. These issues indicate a lack of robust quality control and data management practices.