FDA 483 - Slice Manufacturing LLC - July 22, 2019

Slice Manufacturing LLC in Akron, OH, a medical device manufacturer, was inspected by the FDA from July 11-22, 2019. The inspection revealed significant deficiencies in process validation, acceptance procedures for in-process product, control of non-conforming product, device history records, and the development of production processes, particularly concerning acetabular cups. These issues indicate a lack of adequate quality system controls for manufacturing medical devices.