How to Avoid and Respond to FDA Warning Letters: Guide for U.S. FDA-Regulated Organizations

The following article shows three excerpts from some of the more common "observations" noted in Warning Letters during 2008-2009. (The names have been left out in this article, but are a matter of public record).  Each of these deviations involved environmental conditions (temperature, humidity, etc.) in a variety of cGMP settings; they range from failure to properly monitor temperature at food processing facilities to a lack of temperature records in an aseptic processing area of a drug manufacturing facility. None of the deviations excerpted here are unique, but all are avoidable.

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