FDA 483 - Toby Orthopaedics, Inc. - September 18, 2019

Toby Orthopaedics, Inc. in Miami, FL, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern inadequate design controls for the WOLF® Long Bone Plate System, including validation, output, and transfer, as well as failures in reporting corrections and adverse events for the PANTERA® Humerus Fracture Fixation Plate System and deficiencies in their CAPA process. These issues indicate a lack of robust quality management practices for device development and post-market surveillance.