FDA 483 - Robin Industries Healthcare Division - September 26, 2023

Robin Industries Healthcare Division, a medical device manufacturer in Berlin, OH, was inspected and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, undocumented equipment maintenance and cleaning activities, and a lack of control over critical documents. These issues indicate a systemic breakdown in maintaining a compliant quality management system.