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FDA Investigators Talk Quality Issues And Inspectional ‘Games’ Manufacturers Play

This article was originally published in The Silver Sheet

Executive Summary

There are plenty of typical mistakes that FDA investigators find when inspecting device firms, from failing to adequately document complaints and ensuring proper process validation, to developing ambiguous design inputs during design control activities. Yet what really grates investigators’ nerves is when they have to ask manufacturers several times for procedures and processes that are routinely asked for during an inspection. “Let’s get beyond the things that you know are going to be needed and have them readily available,” says Phil Pontikos, an agency investigator and FDA’s national device expert. In fact, firms that attempt to conceal information or stall an investigator leave themselves open to additional scrutiny by the agency. “If you want to play games, then quite frankly, we’re going to dig deep,” Pontikos says.


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