FDA 483 - Amneal Pharmaceuticals Private - May 12, 2025

Amneal Pharmaceuticals Private in Ahmedabad, India, received a Form 483 with two observations following an FDA inspection. The firm was cited for inadequate control procedures related to manufacturing processes, specifically failing to properly qualify a sterile injection filling machine, which resulted in uncontrolled fill weight variability. Additionally, the inspection revealed a lack of established procedures to prevent microbiological contamination, including deficiencies in personnel monitoring and dynamic airflow visualization studies in classified cleanroom areas.