FDA 483 - Princeton Medical Group Inc - November 21, 2023

Princeton Medical Group Inc, a medical device manufacturer in Franklin, TN, was cited for two significant observations during an FDA inspection. The firm failed to ensure its Class I and Class II medical devices were directly marked with Unique Device Identifiers (UDI) and did not submit required UDI information to the FDA's GUDID. Additionally, the company lacked documented procedures for handling complaints and could not provide complaint files for review.