The Next New Thing In FDA Inspections: Poor Root Cause Investigations
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.
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Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
US agency mostly saw less of the same when it scaled back inspectional activity during COVID-19, but observed more training and equipment issues.
It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.