FDA 483 - Engineered Medical Systems, LLC - February 10, 2023

An FDA inspection of Engineered Medical Systems, LLC in Bartlett, TN, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately investigate nonconformities, implement effective corrective actions, verify their effectiveness, and maintain proper documentation for CAPA activities. These issues indicate a systemic problem in addressing product-related complaints and preventing their reoccurrence.