Skeletal Dynamics, Inc.February 18, 2022

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

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Record Details

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.

Company: Skeletal Dynamics, Inc.
Inspection Date: February 18, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
People: Alex J. Wild
Nydia E. Colon

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ID · fa735a8e-1635-41ec-83e1-51ccab407d43