FDA 483 - Toby Orthopaedics, Inc. - July 15, 2025

Toby Orthopaedics, Inc. in West Miami, FL, a specification developer, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately document design validation for orthopaedic devices, did not conduct required management reviews of its quality system, and neglected to perform annual internal quality audits. Several of these issues were noted as repeat observations.