FDA 483 - D3W Industries Inc - January 17, 2025

D3W Industries Inc, a drug repackager in Novi, MI, was inspected by the FDA, revealing a significant absence of a quality control unit. The inspection also cited a lack of established cGMP procedures for critical operations such as deviations, change controls, and the repacking and relabeling of hand sanitizer. These findings indicate fundamental deficiencies in the firm's quality system.