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Compliance In Focus
Posted by John Lehmann on Tue, Aug 15, 2017

Our Site Got a 483 - Now What?

Your friends from the FDA stopped by and noted several red flags at your site in a Form 483. 483whitepaperimage-1.pngNow what? The most important thing you can do as a principal investigator is accept responsibility for these violations and demonstrate you're taking steps to address them.

As a leading CRO, principal investigators often ask us how to prevent these issues and respond to citations when they do occur. IMARC Research has created a new whitepaper that offers an overview of:

  • The most common deficiencies cited in Form 483s
  • What to do if your site receives one
  • How to avoid Form 483 citations

If you start a new study with the end in mind, prospectively plan to conduct a well-controlled study in order to avoid the commonly encountered pitfalls that whitepaper addresses. Employ critical thinking and creative problem-solving skills to address and correct commonly encountered issues in study conduct.

We encourage you to download our new whitepaper and use for future reference.

Our Site Got a 483 for a Medical Device Study - CTA

Topics: Form 483, Principal Investigator, FDA


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