Maco Bag – FDA 483, Oct 13, 2022

An FDA inspection of Maco Bag in Newark, NY, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to establish written Medical Device Reporting (MDR) procedures, adequately implement corrective and preventive action (CAPA) procedures, and prevent product contamination. These issues indicate a lack of control over critical manufacturing processes and quality management.