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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Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.
Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.
The FDA wants to know why the API firm is still not getting to the root cause of manufacturing deviations.