No cGMP manufacturer wants to receive a Form 483 letter (“Notice of Inspectional Observations”). In such stringently controlled industries as pharmaceutical/biotechnical/medical device development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system. Worse, with the 2009 increase in enforcement staff and the September 2009 change to the response time—now 15 days—the FDA appears to be ramping up its enforcement mandate.

The following article shows three excerpts from some of the more common “observations” noted in Form 483 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 document calibration results for Class 1 sterile devices to a lack of humidity control for manufactured patient assist devices. None of the deviations excerpted here are unique, but all are avoidable.

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