FDA 483 - Alembic Pharmaceuticals Limited - March 24, 2023

Alembic Pharmaceuticals Limited, a sterile drug manufacturer, received a Form FDA 483 citing significant quality control deficiencies. Observations included the failure of the quality control unit to adequately review and approve drug product production records for contract manufactured batches prior to release. Additionally, the quality control unit lacked proper oversight, and internal audit procedures were found to be inadequate, with issues related to auditor training and audit scope.