Medical Device CRO Blog

FDA Warning Letter and Form 483 Week!

Posted by John Lehmann on Mon, Apr 01, 2013

This week is FDA Warning Letter Week at IMARC Research!  Over the next four days, IMARC willFDA Warning Letter and Form 483 Week provide the following blogs to help learn and generate conversation:

  1. Differences and similarities between FDA Warning Letters and Form 483s
  2. Ten tips to avoid when responding to an FDA Warning Letter
  3. Ten tips to practice when responding to an FDA Warning Letter
  4. FDA's assessment when reviewing a reponse to a Warning Letter

We look forward to your comments, questions and discussions on these important and popular topics.

Photo Credit: chrisinplymouth 

 

Topics: FDA, Warning Letters, Form 483s