The FDA’s “Dos” and “Don’ts” for responding to a 483.

Posted on November 13, 2013

DO!
• Include photos where possible.
• Include documentation to provide evidence that corrective actions have been implemented.
• Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask!  If you had the observation at one site, but did not address it at all sites, you will need to make sure that you have corrected ALL instances where that observation could apply.
• Address multiple observations for similar issues as a systemic deficiency. Avoid taking a “Band-Aid” approach
• Be factual and concise.
• Make use of internal and/or external subject matter experts when addressing complex issues. 
• Assign personnel who are not involved in daily operations to remediation projects. You don’t want people both trying to do their jobs and fixing problems at the same time
• Establish realistic timeframes to complete CAPA. The FDA is more concerned with actually fixing it than how fast you can do it; longer is better if you can actually get meaningful results
• If you are going to disagree with an inspector, do so respectfully, and provide a thorough explanation with rigorous supporting documentation.

DON’T!
• Lose focus on what the objectionable condition was and what you are doing to remediate it. Address observations first. Address other issues that you discover later.
• Provide a mountain of paper without including a guide or description on where to find critical information. The FDA cannot know how each facility organizes their documents.
• Exaggerate and claim that extensive corrective and preventive actions will be performed. It’s important to be very clear exactly what it is you plan to do. Setting high expectations and not meeting them will not impress anyone.
• Attempt to justify bad decisions. Accept blame, fix it, and move on.
• Suggest that multiple iterations of the same deficiency are “isolated instances.”
• Ignore the District office and respond directly to the Center. Copying the district office, and even the inspector, on all communication is critical to ensure that everyone is on the same page.
• Assume that the response will resolve all of the issues raised throughout the course of the inspection. You may receive a Warning Letter after an inadequate response to a 483.

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