FDA 483 - Alembic Pharmaceuticals Limited

Alembic Pharmaceutical Limited (Formulation 1) in Panchmahal, Gujarat, India, a finished dosage manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included failures in quality control procedures related to product recall for a mislabeling event and deficient complaint handling. Further issues involved unauthorized access to label storage, inconsistent gowning practices, and inadequate challenging of camera equipment used for lot number printing verification.