FDA 483 - Alembic Pharmaceuticals Limited - August 30, 2022

An FDA inspection of Alembic Pharmaceuticals Limited, a sterile pharmaceutical manufacturer in Vadodara, Gujarat, India, revealed two significant observations. The firm's aseptic processing areas were found to have deficient air supply due to inadequate airflow visualization studies. Additionally, the company failed to properly record and justify deviations from written procedures, with multiple investigations lacking appropriate preventative actions to prevent reoccurrence.