Home » FDA’s Closeout Letters Will Be Based on Verified Corrections
FDA’s 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 warning letter will be responsible for issuing the closeout letter after evaluating the corrective action the drugmaker has undertaken. “A closeout letter will not be issued based on representations that some action will or has been taken,” Siobhan DeLancey of the FDA’s Office of Public Affairs said.
Drug Industry Daily
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