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Responding to an FDA 483

How to Respond to FDA 483s and Warning LettersYou have just been issued a FDA 483 warning letter -- now what?

Your main objective is to limit damage to the company and get into compliance as soon as possible. If you show contempt for the agency, chances are you will be forced into compliance through legal action, with increased expenses, a possible loss of business and adverse publicity. If instead you show FDA you are complying without the need for further action, chances are the agency will work with you to achieve compliance.

The investigator will try to elicit your response to each point in the FDA 483. In cases where your responses can be made without any uncertainty, make them. But if you are not sure of your response, it is better to explain to the investigator that you will supply a written response directly to an FDA office.

Alan Schwartz of mdi Consultants recently explained that, even if you respond verbally to each point, it is crucial to send a written response immediately. This assures your response is accurately given to all parties who have a say in whether a Warning Letter should be issued.

Observations on the FDA 483 are just the investigator's opinions. These observations are not always supported for additional legal action by the district office or the Division of Compliance in Washington, but the investigator is the main advocate for additional action.

And Schwartz should know. He is a former FDA supervisor of field investigations and now acts as Executive VP with mdi Consultants.

Check out the following resources for more information:


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1 Comment:

  1. Regulatory Consulting said...
    Thanks for this useful post!!!!!!!!!!

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