FDA 483 - FloSpine, LLC - November 18, 2022

FloSpine, LLC, a medical device manufacturer in Boca Raton, FL, received two observations during an FDA inspection. The firm failed to adequately investigate device complaints, specifically concerning a Panama Cervical Plate system, and did not properly evaluate a new supplier for this critical device. These deficiencies led to multiple non-conformances and indicate significant issues in the firm's quality system regarding complaint handling and supplier management.