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In Brief: GMP inspections

This article was originally published in The Tan Sheet

Executive Summary

GMP inspections: HHS Inspector General plans to assess FDA's "ability to meet its statutory requirement to inspect drug and device manufacturers every two years," according to the IG Work Plan for FY 1998. A report is expected to be issued in FY 1999. "Such inspections are critical," the IG notes, and "previous OIG work in this area indicated that FDA is not meeting this requirement." If FDA cannot conduct the inspections OIG will "examine the agency's efforts to develop alternative methods to assess compliance with good manufacturing practices." The IG also will review FDA's process for handling citizen's petitions and will assess FDA efforts to improve labeling of Rx drugs. Other initiatives, including review of FDA use of credit cards for small purchases, evaluation of the effects of FDA issuance of warning letters for inspection violations, and review of FDA's regulation of institutional review boards, all are carried over from previous IG Work Plans ("The Tan Sheet" Dec. 2, 1996, p. 10)...
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