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Compliance In Focus
Posted by Jacqui Lingler on Wed, Apr 3, 2013

Top 10 “Do NOT” Tips for FDA Responses

This week is FDA Warning Letter Week at IMARC!  Did you check out the first blog in a series ofTop 10 Do NOT Tips for FDA Responses 4 titled Differences and similarities between FDA Warning Letters and Form 483s? Next learn the Top 10 “Do NOT” tips when responding to an FDA Warning Letter or Form 483:

  1. Do NOT be late! 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. Do NOT pass the buck! Take responsibility for findings noted and don’t pass the blame on to employees that are no longer with the organization.
  3. Do NOT blame others in the industry! Your response letter is not the time to raise awareness of issues in your industry. Pointing out errors or deficiencies  of your  competitors will not win you any points with the agency.
  4. Do NOT incorrectly identify causes of the findings! You have time to 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.
  5. Do NOT provide too little documentation! The agency will want to see documentation or explanation for non-compliances. Not fully addressing each item or providing too little documentation could be interpreted as not fully understanding the regulation violated.
  6. Do NOT provide too much documentation! Avoid long-winded, rambling responses. Going on and on about a particular violation or its cause is not an effective response. Keep responses concise, focused, with documentation of the cause and a detailed plan to avoid similar errors in the future.
  7. Do NOT minimalize significance of the citation! The agent thought the violation was significant enough to note it, enough said!
  8. Do NOT assign response to an intern! When a Warning Letter is issued, it is usually addressed to the top corporate management, purposely! The citations warrant attention and response from the top level of any organization. Not delegating the response letter to a junior staff member is step one in taking responsibility and committing to an action plan to avoid issues in the future.
  9. Do NOT wait to implement corrective actions! Corrective action planning and implementation should ideally start before the agent leaves the building. The agency will most likely follow-up at a later date to assess corrective action plan implementation and effectives. Don’t delay in fixing the problems- you may avoid new ones starting.
  10. Do NOT make promises you can’t keep! 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 any horror stories to share of responses “gone bad”? Can you share additional “Do NOT” tips when responding to the FDA?

 Photo Credit: Sam UL

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Topics: Form 483, FDA Warning Letters, FDA Responses


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