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Compliance In Focus

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Posted by Sandra Maddock on Mon, Jul 09, 2018

Do Form FDA 483s Matter Anymore?

For clinical researchers, our “grade card” comes when the FDA inspects us.  We all want to be told that we’ve operated in a compliant manner and that there were no findings.  The alternative is to receive a Form FDA 483 (483) for significant deviations at the close of the inspection.  When I got my first 483 as a research coordinator 18 years ago, I remember thinking to myself “I’m not going to let that happen again.”  In my opinion, it was an indication that we had not delivered A+ work.  Since the stakes are so high in this environment, and we’re asking patients to trust us to perform, it was a big wake up call for me. 

Topics: IMARC Research, FDA, Form 483s

Posted by John Lehmann on Wed, Jan 03, 2018

FDA Warning Letter and Form 483 Week!

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

Topics: FDA, Warning Letters, Form 483s

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