FDA 483 - Sustain Medical, LLC - March 21, 2024

An FDA inspection of Sustain Medical, LLC in Concord, MA, from March 11-21, 2024, revealed one significant observation. The firm failed to provide required information to the Global Unique Device Identification Database (GUDID) for its Tru-Flo Ortho Surgical Filter System. This indicates a lapse in compliance with medical device identification regulations.