It is extremely important to promptly respond to any correspondence from FDA, particularly the FDA-483 or a Warning Letter. If a prompt complete response is made to the FDA-483 the company may avoid receiving a Warning Letter. If no response, or an inadequate response is made it is very likely that FDA will issue a Warning Letter to the company. If a foreign firm receives a Warning Letter from FDA the company will most likely be place on an Automatic Detention list which means that none of their products will be permitted entry into the United States until the issues are corrected and FDA has verified the corrections. That is a very long process and will take many months to a year or more. For domestic firms this could be the beginning of further, much more serious regulatory action by FDA. This webinar will explain the FDA processes and provide guidance on how to manage these issues.

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by Jay Sirois, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA

 

Webinar Objectives
  • Learn the significance of FDA-483s and Warning Letters.
  • Understand the risk if prompt response to these documents are not made.
  • Understand FDA enforcement procedures particularly as they relate to managing FDA 483s and Warning Letter responses.
Seminar Information
Date Presented:
April 17, 2018 2:00 PM Eastern
Length:
1 hour
CHPA Member Price:
$99.00
Non-Member Price:
$249.00
Responding to 483s and Warning Letters
Speaker Information
Robert Fish  [ view bio ]
Individual topic purchase: Selected
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