FDA 483 - Apitoria Pharma Private Limited - December 12, 2025

An FDA inspection of Apitoria Pharma Private Limited's sterile Active Pharmaceutical Ingredient (API) manufacturing facility in Pashamylaram, India, occurred from December 1 to December 12, 2025. The inspection resulted in a Form FDA 483, citing several objectionable conditions related to manufacturing quality and control. Key issues included inadequate airflow visualization studies for ISO 5 aseptic filling lines, which failed to properly assess airflow at the filling manifold, impact on APIs, or effects of interventions. Additionally, the facility lacked sufficient sampling in production areas across various manufacturing blocks to confirm the adequacy of cross-contamination prevention procedures. A critical observation also noted deficiencies in the aseptic process simulation study used to qualify sterile APIs; specifically, it did not include worst-case challenge organisms or demonstrate successful organism detection. These observations indicate concerns with sterility assurance and contamination control, requiring Apitoria Pharma Private Limited to thoroughly investigate, implement robust corrective actions, and formally respond to the FDA to ensure compliance with regulatory standards.