FDA 483 - DRAPER PRODUCTS, INC./R. SABEE CO. LLC - July 18, 2019

An FDA inspection of DRAPER PRODUCTS, INC./R. SABEE CO. LLC in Appleton, WI, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish proper procedures for handling complaints and for medical device reporting. These issues indicate a lack of adequate controls for post-market surveillance and reporting of adverse events.