FDA 483 - Dymax Corp - July 30, 2021

An FDA inspection of Dymax Corp, a medical device manufacturer in Zelienople, PA, identified a significant issue with the control of non-conforming products. Specifically, the firm failed to adequately control Breast Biopsy System medical devices containing incorrectly wired cooling fans, resulting in the release and distribution of faulty units. This indicates a lapse in quality system controls for product specifications and release.