FDA 483 - Klarity Medical Products LLC - July 09, 2021

An FDA inspection of Klarity Medical Products LLC in Heath, OH, a manufacturer of thermoplastic masks and vacuum bags, revealed significant deficiencies in their quality system. The firm failed to establish or implement numerous critical procedures, including those for acceptance activities, corrective and preventive actions, purchasing controls, training, device master records, device history records, and document control. These findings indicate a broad lack of adherence to quality system requirements for medical device manufacturing.