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

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.