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Warning Letter Recipients Can Get ‘Closeout Letters’ From FDA

Sept. 21, 2009
Sponsors or investigators 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 drug- or devicemaker has undertaken.
Clinical Trials Advisor