FDA 483 - Marlen Manufacturing & Development Co. - June 08, 2022

Marlen Manufacturing & Development Co., a medical device manufacturer in Bedford, OH, was inspected by the FDA. The inspection revealed two repeat observations concerning inadequate procedures for equipment calibration, specifically for sealing machines used in manufacturing ostomy and biliary bags, and insufficient monitoring of supplier performance. These issues indicate a lack of established controls to ensure product quality and supplier compliance.