FDA 483 - Apitoria Pharma Private Limited - May 19, 2023

An FDA inspection of Aurobindo Pharma Limited, Unit XIV, an API manufacturer in Anakapalli District, India, revealed significant deficiencies. Observations included inadequate manufacturing equipment cleaning and storage, improper resealing of API product drums, and raw materials stored outside specified conditions. Additionally, laboratory controls were found lacking, with issues in instrument verification, secondary standard qualification, and chromatographic test precision.