FDA 483 - Alembic Pharmaceuticals Limited - February 18, 2026

An FDA inspection of Alembic Pharmaceuticals Limited in Vadodara, India, a sterile drug manufacturer, revealed significant deficiencies in their manufacturing processes. The firm failed to adequately investigate a media fill contamination and exhibited multiple deficient aseptic practices during cleaning and filling operations. Additionally, issues were noted with environmental monitoring, media fill simulations, airflow visualization studies, and the integrity testing of critical equipment, raising concerns about product sterility.