483
Van Duzen, Inc. dba MedCADVan Duzen, Inc. dba MedCAD – FDA 483, Aug 2, 2024
Record Details
An FDA inspection of Van Duzen, Inc. dba MedCAD in Dallas, TX, a Class II medical device manufacturer, revealed a significant quality system deficiency. The firm failed to adequately validate the cleaning instructions for its AccuPlan System, a Class II medical device. This lack of validation poses a potential risk of patient infection, as noted in the firm's own risk analysis.
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ID · b4ec9882-3c8a-419c-a2b3-8450cb761c68
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