FDA Investigators Play Fast And Loose With Quality System Inspection Technique, Experts Say – But Is It Par For The Course?
• By Shawn M. Schmitt
US FDA’s Quality System Inspection Technique – or QSIT – isn’t being followed to the “T” by many agency investigators, say industry experts, including two who authored the auditing approach in 1999. Sources tell Medtech Insight that QSIT, designed to ensure that investigators look at the most important compliance issues and ask pertinent questions linked to four major quality system subsystems, is routinely bypassed by investigators bent on inspecting their own way. But it’s not unreasonable for investigators to deviate from QSIT as they follow leads wherever they may go, says a former director of FDA’s Investigations Branch who left the agency in June. Meanwhile, a key player in the development of the Quality System Inspection Technique, Tim Wells, explains why he’s drafting a “new” QSIT for industry use.
Two authors of US FDA’s Quality System Inspection Technique say too many agency investigators aren’t always following the auditing approach when conducting facility inspections, often catching device manufacturers by surprise as they manage onsite FDA audits.
The claims come as one of the authors – Tim Wells – says QSIT is outdated and desperately needs a...
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