Marlen Manufacturing & Development Co. – FDA 483, May 6, 2026

An FDA inspection of Marlen Manufacturing & Development Co. in Bedford, OH, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation for process validation, production controls, and risk management processes. Additionally, the firm failed to enter required Unique Device Identification (UDI) numbers for its medical devices into the GUDID database.