FDA 483 - Apitoria Pharma Private Limited - August 12, 2021

An FDA inspection of Aurobindo Pharma Limited (Unit I), an Active Pharmaceutical Ingredient Manufacturer in Doulatabad, India, revealed significant quality system deficiencies. The firm failed to adequately qualify suppliers, implement scientifically sound sampling plans, and ensure components were tested prior to use. Additionally, issues were noted with the evaluation of manufacturing changes, the scientific soundness of investigations into discrepancies, equipment maintenance, and the timely documentation of quality-related activities.