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It's in the mail -- Responding to an FDA warning letter

event report is not a warning letter.

A warning letter can come from one of the FDA's district offices, such as the Minneapolis District, or one of its product-based centers, such as the Center for Drug Evaluation and Research.

Warning letters generally are sent to the highest known official in an organization (e.g., president or CEO). Warning letters usually require a response w......

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Source:wistechnology.com By Patricia Kaeding 08/12/05


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