FDA 483 - Faico Medical LLC - May 02, 2023

Faico Medical LLC, a medical device manufacturer in Boca Raton, FL, was inspected by the FDA, revealing significant deficiencies in their complaint handling system. The firm failed to adequately document rationales for not investigating serious (Level 1) complaints and did not make required medical device reports to the FDA for events involving patient pain and implant movement. These issues indicate a breakdown in the firm's quality system regarding complaint management and regulatory reporting.