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Compliance In Focus
Posted by John Lehmann on Tue, Nov 29, 2016

10 Keys For Responding to an FDA Warning Letter or Form 483

Each year, IMARC releases a whitepaper listing of the top reasons for FDA warning letters, here is10 Keys.jpg the listing for 2015. Provided below are 10 Tips to consider when responding to a FDA Warning Letter or Form 483: 

  1. Respond on time: A response is not required for a 483, but providing the FDA with a formal response is good practice. If received past 15 days of issue, the agency will not consider the response in their decision on subsequent action. A due date will be noted in a Warning Letter, usually 15 calendar days. An extension can be requested with justification of why more time is needed. 
  2. Focus on importance of the warning: Take the 483 or Warning Letter seriously and understand the larger message the agency is sending. 
  3. Assign a “response team”: The letter or Form 483 will most likely be addressed to top level management or the principal investigator. Those ultimately responsible should assign a group to review and draft a response to the FDA’s findings. Those responsible should be actively involved in the development of the response and any correction action plans developed. 
  4. Consult with legal counsel if necessary: This is especially important if findings affect product and public safety. 
  5. Respond in descending order of importance: The list of findings will be listed in descending order. Take the agency’s example and respond in the same order. 
  6. Take responsibility: Accept responsibility as top level management or principal investigator. Not passing the buck will demonstrate recognition of seriousness of violations and commitment to comply with applicable laws and regulations. 
  7. Address each item individually: Site each citation as reference when responding. 
  8. Identify correct causes of findings: Thoroughly investigate the root cause of the findings noted. Don’t just pick training because it seems to be the easiest, most identifiable culprit. Take the time to look into the processes and systems of your organization and correctly identify the cause. 
  9. Develop corrective action plans: Describe correction action plans to address each citation listed. Describe the steps to address other areas which may be subject to the same deficiency. Include how each action plan will be measured for efficacy. 
  10. Set obtainable goals: Develop corrective action plans that are reasonable for your organization with timelines that are realistic. Assign management to individual correction action plans or develop teams of employees to implement plans and assess the effectiveness. Again, the agency can and may follow-up and will issue additional Warning Letters for incomplete or ineffective action plans resulting in additional violations.

Do you have additional tips or tools for responding to FDA Warning Letters or Form 483s? Have any of these tips worked for you when responding to the FDA?

Guidance for Ensuring Your Clinical Study | IMARC Research

 

photo credit: Jdmoar Keys via photopin (license)

Topics: Form 483, FDA Warning Letters

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