FDA 483 - Apitoria Pharma Private Limited - December 01, 2025

An FDA inspection of Apitoria Pharma Private Limited, a sterile API manufacturer in J.N.Pharamacity, Telangana, India, revealed significant deficiencies in aseptic processing. Observations included inadequate airflow visualization studies for aseptic filling lines, a lack of environmental sampling to support cross-contamination controls, and an aseptic process simulation study that failed to assess worst-case challenge organisms.