FDA 483 - Piramal Pharma Solutions Inc. - December 10, 2025

An FDA inspection conducted between December 3 and December 10, 2025, identified significant deficiencies at the firm, indicating non-compliance with Good Manufacturing Practices. The inspection, documented in an FDA 483, revealed four primary areas of concern. First, procedures for preventing microbiological contamination of sterile drug products were inadequate. Airflow visualization studies for aseptic processing failed to simulate actual manufacturing conditions, showing turbulent airflow and insufficient operator intervention simulation, raising concerns about sterility assurance. Second, production and process controls were found to be deficient. This included an inability to assure that visual inspection personnel could consistently identify product defects, and a lack of clear procedures for repeating failed endotoxin tests, allowing analysts to repeat tests until passing results were obtained. Third, controls over computer systems and data integrity were insufficient. The firm failed to review audit trails for endotoxin testing software, and a supervisor held multiple access privileges. Additionally, there was no reconciliation process for downloaded test result forms. Finally, the firm demonstrated a failure to thoroughly investigate unexplained discrepancies and batch failures. Two specific investigations were cited for not including critical interviews with personnel or reviews of maintenance work orders, leading to incomplete root cause analyses for issues like equipment contamination and defective product crimps. The firm is expected to address these observations with comprehensive corrective actions to ensure compliance with regulatory standards under the Federal Food, Drug and Cosmetic Act.