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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.

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Warning Letters Special Report: Top Problem Areas Were Investigations, Testing And Sterility

Drug GMP warning letters last year cited testing inadequacies and poor batch failure and complaint investigations more than any other problem, this third part of our in-depth series reports, followed by sterility assurance issues that were somewhat driven by concerns about water systems. Most were US-focused – a pandemic limitation but also a reminder that drug GMP problems are not limited to China and India.

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.

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