The Next New Thing In FDA Inspections: Poor Root Cause Investigations
Executive Summary
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.
You may also be interested in...
More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy
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.
Fewer Observations, Shift In Emphasis Seen In FDA's Pandemic-Reduced Inspections
US agency mostly saw less of the same when it scaled back inspectional activity during COVID-19, but observed more training and equipment issues.
Hiding Cancer Drug Manufacturing Records Costs Fresenius Kabi $50M In US Settlement
It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.