FDA 483 - May Dental Arts, LLC - December 06, 2023

May Dental Arts, LLC, a medical device contract manufacturer in Fenton, MO, was cited with five observations during an FDA inspection. The firm failed to properly label its Class II medical devices with Unique Device Identifiers (UDI) and did not submit required information to the Global Unique Device Identification Database (GUDID). Additionally, the inspection revealed inadequate labeling procedures, a lack of a device master record, and unvalidated manufacturing processes for implant restorations.