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ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready Anytime Soon; Investigator Training, Retention Pose Challenge For FDA

This article was originally published in The Gray Sheet

Executive Summary

More details about FDA's new commodity-specific inspectional approach continue to emerge, including news that the Office of Regulatory Affairs is under pressure to train agency investigators while simultaneously dealing with the loss of several highly trained auditors to the agency's device center. All of this comes amid a sign-off process on "program alignment" that will extend all the way to Capitol Hill.


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