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

Source: https://www.globalkeysolutions.net/records/483/toby-orthopaedics-inc/0943b01a-c090-4507-8f0d-b314c68331aa

> FDA 483 for Toby Orthopaedics, Inc. on September 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Toby Orthopaedics, Inc.
- Inspection Date: 2019-09-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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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## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/toby-orthopaedics-inc/185568fb-eec0-41e6-8814-637cd6dbe706

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6