FDA 483 - Shilpa Medicare Limited - March 10, 2023

An FDA inspection of Shilpa Medicare Limited's Control Testing Laboratory in Hyderabad, India, revealed significant deficiencies in laboratory control mechanisms. Observations included the lack of a validated deaeration/degasification process for dissolution media and failures to establish and maintain traceability for dissolution baskets. The firm also failed to follow its own established test procedures for dissolution equipment, indicating a breakdown in quality control practices.