FDA 483 - Alembic Pharmaceuticals Limited - March 24, 2023

During an FDA inspection conducted from March 16 to March 24, 2023, Alembic Pharmaceuticals Limited, a sterile drug manufacturer in Vadodara, Gujarat, India, received a Form FDA 483. The inspection revealed significant deviations from Current Good Manufacturing Practices (cGMP). The primary observations concerned the quality control unit's oversight and internal audit processes. Firstly, the company failed to ensure adequate review and approval of drug product production and control records by its quality control unit before releasing or distributing batches. Specifically, there was no documented thorough review of batch records for products manufactured by their contract manufacturing organization (CMO) and shipped to the United States. The existing batch release procedure lacked detailed review descriptions, and the site's Quality Head confirmed analytical data was not routinely reviewed, nor was a checklist used for review content. Secondly, the quality control unit demonstrated deficiencies in its responsibility to approve procedures impacting drug product quality. Internal audits were deemed inadequate because personnel lacked documented specific training or experience for auditing assigned areas. Audit checklists provided insufficient detail on what was being audited, and audits were conducted only periodically without unannounced checks. Alembic Pharmaceuticals Limited is required to respond to these observations with comprehensive corrective and preventive actions to ensure compliance with cGMP regulations and prevent recurrence of the identified issues. This includes strengthening batch record review procedures, enhancing auditor training and audit methodologies, and improving overall quality unit oversight.