FDAnews Device Daily Bulletin

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