Free Article Download:
"How to Respond to (and Avoid)
FDA Form 483s"

With the recent increase in FDA enforcement staff and the 15-day time limit for responding to negative observations, quality professionals need to know how to respond quickly and effectively after an FDA inspection produces a Form 483 Letter. However, a rushed response may cause more trouble than it solves.

Download the article to learn 10 steps towards formulating an effective response that will not only offset the risk of further agency action, it will provide several ways to improve your quality systems for controlled and critical environments.

An initial response must detail your intentions to address all deviations noted, outline a feasible time-frame for corrections, and promise follow-up correspondence with the agency that will provide proof of corrective action.

This article includes 10 best practices for responding to 483 observations and suggestions for avoiding deviations and product loss in applications that involve temperature, humidity, and other monitored variables.

Three excerpts from some of the more common observations noted in Form 483 Letters during 2008-2009 are referenced, followed by a 10-point checklist that should make responding within the new 15-day time limit more manageable.

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