FDA Urged To Get Specific In Facility Inspection Reports

Law360, New York (October 23, 2013, 8:50 PM EDT) -- A trade group has asked the U.S. Food and Drug Administration to cite specific regulations when making observations about a food or dietary supplement facility inspection, the organization said Monday, arguing that the lack of detail promotes a “regulatory guessing game.”

The American Herbal Products Association has learned that the FDA tells inspectors not to divulge the regulatory basis for their observations in a so-called Form 483 or to quote regulatory provisions, the group said in a citizen petition dated Oct. 17. When the inspected company...
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