FDA 483 - Amneal Pharmaceuticals Private - May 12, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · c70ee925-15e6-410e-aa37-5aa316352e1d