FDA 483 - Alembic Pharmaceuticals Limited - February 06, 2021

Alembic Pharmaceuticals Limited in Vadodara, India, was inspected by the FDA from January 28 to February 6, 2021, revealing significant deficiencies. The inspection cited issues in aseptic processing, environmental monitoring, validation of sterile drug product manufacturing, equipment design, airflow control, and quality control unit authority. These observations indicate a lack of adequate controls to prevent microbiological contamination and ensure the sterility and quality of drug products.