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FDA’s Closeout Letters Will Be Based on Verified Corrections

September 11, 2009

FDA’sitting Closeout Letters Will Be Based on Verified Corrections
Companies that have resolved issues in warning letters from the FDA dated Sept. 1 or later — and have passed inspections that verify the corrective action — are eligible for closeout letters. The FDA office that originally sends a notice letter will be responsible conducive to issuing the closeout letter subsequent evaluating the corrective agent action the drugmaker has undertaken. “A closeout letter will not subsist issued based on representations that more action will or has been taken,” Siobhan DeLancey of the FDA’session Office of Public Affairs said.

Written by Samanta · Filed Under FDA News