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Home » Med Pen Concepts Lacking Basic Product Documentation for Plasma Pen, Form 483 Says
Med Pen Concepts Lacking Basic Product Documentation for Plasma Pen, Form 483 Says
An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices.