Apex Healthcare Limited – FDA 483

During an inspection from June 12-15, 2023, Apex Healthcare Limited in Ankleshwar, Gujarat, India, was cited for significant deficiencies in their quality control and data integrity practices. Observations included inadequate procedures for reviewing laboratory control records and audit trail error messages, insufficient controls to prevent data loss in computerized systems, and the absence of a label reconciliation procedure for finished API batches. These issues indicate a lack of robust controls over critical manufacturing and testing data.