FDA 483 - Single Source Medical LLC. - December 06, 2023

Single Source Medical LLC. in North Liberty, IN, a medical device manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, insufficient monitoring of a validated passivation process, failures in acceptance activities, and deficiencies in complaint handling procedures. These issues indicate a systemic breakdown in maintaining quality control and compliance with established procedures.