FDA 483 - Alembic Pharmaceuticals Limited - February 06, 2021

Alembic Pharmaceuticals Limited, a sterile pharmaceutical manufacturer in Vadodara, Gujarat, India, was cited for significant deficiencies in its aseptic processing, environmental monitoring, and validation of sterile manufacturing processes. The inspection revealed issues with inadequate scientific justification for sampling, improper gowning, insufficient equipment qualification, and a quality control unit that failed to fully investigate microbiological contamination incidents. These findings indicate a serious lack of control over critical aspects of sterile drug production.