Comar Inc. – FDA 483, Apr 18, 2024

Comar Inc. in Buena, NJ, a contract manufacturer, received a Form FDA 483 with four observations during an inspection from April 15-18, 2024. The observations primarily concern inadequate quality system procedures, including issues with corrective and preventive actions, process controls, environmental monitoring in cleanrooms, and employee training documentation. These findings indicate significant deficiencies in the firm's quality management system.