FDA 483 - Strides Pharma Science Limited

Strides Pharma Science Ltd. in Bangalore, India, received a Form 483 with five observations during an FDA inspection. The firm was cited for significant deficiencies in laboratory controls, including unvalidated microbial identification methods and data integrity issues with chromatography systems. Other major findings included failure to retain electronic audit trail data, inadequate equipment cleaning practices leading to potential cross-contamination, and insufficient controls over computerized manufacturing recipes and component testing.