Quadm Technologies, Llc – FDA 483, Jan 8, 2026

Quadm Technologies, Llc in Hamilton, NJ, a medical device manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in process validation for cleaning, passivation, and CNC milling, as well as inadequate procedures for controlling non-conforming products, monitoring process parameters, and equipment maintenance. These issues indicate a lack of robust quality system controls for critical manufacturing processes.