FDA 483 - Alliance Tech Medical, Inc - August 20, 2025

An FDA inspection of Alliance Tech Medical, Inc. in Granbury, TX, a repackager/relabeler, identified a significant issue related to supplier management. The firm failed to adequately establish and maintain records for acceptable suppliers, contractors, and consultants. This included missing Supplier Understanding Forms for a contract manufacturer and a lack of audits for a contract warehouse, indicating a breakdown in their quality system for supplier control.