QUOTED. Dec. 6, 2017. Enno Siemsen.
Executive SummaryCheck out what University of Wisconsin-Madison professor Enno Siemsen had to say about repeat facility visits from US FDA investigators after a study found that a device-maker's recall hazard increases 21% when it's inspected a second time by the same auditor.
"Investigators do develop ties with the people at the plant, and the moment that happens, they become less adversarial and don’t ask the right questions anymore. And they don’t provide the right feedback anymore, which means one of the key mechanisms of how they function is basically not there anymore." – Enno Siemsen, professor, University of Wisconsin-Madison
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