FDA 483 - Med Pen Concepts, LLC - January 24, 2024

An FDA inspection of Med Pen Concepts, LLC in Woburn, MA, revealed 12 significant observations regarding their quality management system for Plasma Pen medical devices. The firm demonstrated widespread failures in design control, corrective and preventive actions, device history records, and various acceptance and validation procedures. Several issues were repeat observations from a previous inspection, indicating persistent non-compliance.