483
Toby Orthopaedics, Inc.FDA 483 - Toby Orthopaedics, Inc. - September 18, 2019
Record Details
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.
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ID · 0943b01a-c090-4507-8f0d-b314c68331aa