483
Alliance Tech Medical, IncAlliance Tech Medical, Inc – FDA 483, Aug 20, 2025
Record Details
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.
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- Dallas District Office
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ID · e0d0c6e6-a19c-49e4-ae4a-066877ccf1d6
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