FDA 483 - AMT Medical - December 13, 2019

Advantage Manufacturing Technologies, Inc. in Monroe, WA, a contract manufacturer of Class 2 implantable bone screws and plates, was cited for two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically not verifying the full implementation of a corrective action. Additionally, evaluations of out-of-calibration equipment and associated remedial actions were not documented.