FDA 483 - Case Medical, Inc. - October 12, 2023

An FDA inspection of Case Medical, Inc. in Bloomfield, NJ, a medical device manufacturer, revealed significant deficiencies in their quality management system. The firm failed to adequately establish and close corrective and preventive actions in a timely manner, maintain supplier requirements, and implement an adequate risk analysis procedure. These issues indicate a systemic breakdown in ensuring product quality and safety.