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Quality Quest - FDA 483 Letters Should Trigger Action - Not Panic

Wed, 03/10/2010 - 1:29pm
pharmpromag

FDA 483 letters are expected to increase this year, reflecting the FDAs recent staff expansion and rewrite of the FDA 483 Letter rules to narrow response time to the new 15-day window, and the hard truth that many quality managers in pharmaceutical processing plants think they are in compliance when they are not.

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