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BFFs With FDA? Repeat Visits From Investigators Can Lead To Poor Device Quality, Recalls, Study Suggests

 
• By Shawn M. Schmitt

When a US FDA investigator is overly familiar with a company and its people, it can lead to a weaker facility inspection that might not uncover quality system problems – which in turn could lead to troublesome devices and recalls. So says a study conducted by professors at the University of Wisconsin, Indiana University and the University of Minnesota, which found that a device-maker's recall hazard increases 21% when it's inspected a second time by the same investigator. Even more concerning: The recall hazard shoots up 57% after an investigator's third audit of a firm. Might rotating investigator assignments help? And how might the agency's new "program alignment" inspectional scheme affect how often an investigator visits a particular firm?

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Device-makers repeatedly inspected by the same US FDA investigators run the risk of making poor-quality products and conducting costly recalls. That's the conclusion of a study conducted by business and management professors at the University of Wisconsin, Indiana University and the University of Minnesota.

A 17-page paper published in August in the journal Manufacturing & Service Operations Management details the study, titled "Do Plant Inspections Predict Future Quality? The Role of Investigator Experience

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