FDA WARNING LETTER CONSISTENCY, BIENNIAL INSPECTION PERFORMANCE TO BE AUDITED BY HHS' OIG; AGENCY REGULATION OF IRBs ALSO SLATED FOR INVESTIGATION IN FY 1996
This article was originally published in The Gray Sheet
Executive SummaryFDA uniformity in issuing warning letters is targeted for audit by HHS' Office of the Inspector General during the current fiscal year, according to an IG work plan for FY 1996. OIG says it will initiate a study "to evaluate the process and effects of issuing warning letters for violations identified during FDA inspections."
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