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OIG work plan

This article was originally published in The Gray Sheet

Executive Summary

HHS Office of the Inspector General will assess FDA's ability to meet its statutory requirement to inspect device and drug manufacturers every two years, according to OIG's work plan for fiscal 1999. "If FDA is unable to meet this legal requirement, we will examine the agency's efforts to develop alternative methods to assess compliance with good manufacturing practices," it states. Other FDA-related initiatives include an evaluation of the agency's process and effects of issuing warning letters
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