FDA 483 - Apitoria Pharma Private Limited - November 18, 2022

The FDA inspection of Aurobindo Pharma Limited Unit IX revealed significant deficiencies across multiple areas of its API intermediate manufacturing. The firm's investigations into Out of Specification results and market complaints were found to be scientifically unsound and incomplete. Furthermore, critical processes such as process validation, analytical method validation, equipment cleaning validation, and laboratory control mechanisms, including data integrity, were all deemed inadequate.