483
DRAPER PRODUCTS, INC./R. SABEE CO. LLCDRAPER PRODUCTS, INC./R. SABEE CO. LLC – FDA 483, Jul 18, 2019
Record Details
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.
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ID · a707d981-32ea-4ab2-9848-316c622a0e07
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