FDA 483 - Cerner Corp - June 21, 2017
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Cerner Corporation, a medical device manufacturer in Kansas City, MO, was cited for significant deficiencies in its complaint handling and reporting processes. The inspection revealed failures to submit Medical Device Reports (MDRs) for serious software malfunctions and to report device corrections made to reduce health risks. Additionally, the firm's complaint handling procedures were not consistently implemented, leading to potential patient safety issues going unflagged.
ID · 37b6dc31-5298-4329-b275-b15180d2adab