# FDA 483 - Skeletal Dynamics, Inc. - February 18, 2022

Source: https://www.keypedia.com/records/483/skeletal-dynamics-inc/fa735a8e-1635-41ec-83e1-51ccab407d43

> FDA 483 for Skeletal Dynamics, Inc. on February 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Skeletal Dynamics, Inc.
- Inspection Date: 2022-02-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Skeletal Dynamics, Inc. in Miami, FL, a medical device specification developer, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the establishment and adherence to procedures for incoming product acceptance, supplier management, and device history records. These issues indicate a lack of adequate controls to ensure product quality and compliance.

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)
- [Nydia E. Colon](https://www.keypedia.com/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.keypedia.com/companies/skeletal-dynamics-inc/01c75cc2-64c2-4b6f-9923-d6f13c178f71

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