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FDA inspectors occasionally show lack of "respect" but not "retaliation," FDAer says.

This article was originally published in The Tan Sheet

Executive Summary

FDA INSPECTION PROGRAM "CULTURE PROBLEMS" DO NOT INCLUDE RETALIATION, FDA Midwest Region Director Burton Love said at a Sept. 20 conference on regulatory compliance sponsored by FDA and the Parenteral Drugs Association in Bethesda, Md. FDA's Office of Regulatory Affairs has been examining the issue of alleged retaliation by FDA inspectors, Love said. Although the agency may have "culture problems," he said, "my observation is that we...probably don't have what is called `retaliation.'" However, he added, "we occasionally have people that don't treat other people with respect."
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