483
Toby Orthopaedics, Inc.FDA 483 - Toby Orthopaedics, Inc. - July 15, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Office
- Florida District Office
- Person
Open in Dashboard
ID · 43befddc-4c0e-4b01-b7b6-972abe03ea9f