Anticipating and Closing Out FDA Warning Letters
Abstract:Anticipating and Closing Out FDA Warning Letters
How can an FDA regulated company know that a Warning Letter is definitely on its way? What are the signs that can help firms anticipate a letter from the regulator? What is the groundwork that can be done before the receipt of the Warning Letter so that when it indeed arrives, the company is ready for it and implements the close-out process quickly and effectively? The answers to these questions are vital in ensuring the FDA Warning Letter response and close-out program is handled in a thorough manner that leaves nothing to chance.
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