FDA 483 - OMT, LLC - September 02, 2022

An FDA inspection of GMT, LLC, a medical device specification developer in Fort Lauderdale, FL, revealed three significant repeat deficiencies. The firm failed to adequately establish procedures for design validation, specifically regarding aging studies for OMT Spetzler Neuro Patties, and had not properly implemented its quality audit procedure. Additionally, the inspection found that procedures for ensuring purchased products and services conform to requirements were not adequately established, leading to issues with supplier complaint handling.