FDA 483 - Davion Inc - January 24, 2025

Davion Inc, an OTC drug manufacturer in Newark, NJ, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to investigate deviations and prevent cross-contamination, with one observation being a repeat. Additionally, the facility's buildings were found not to be maintained in a good state of repair, exhibiting chipped paint and unknown white powder in production and storage areas.