Don't Ignore 483s…it's in Your Best Interest to Respond in Writing

Even though there’s no regulatory requirement to respond to an FDA 483 inspectional observations report, it’s in your best interest to do so in writing, according to FDA sources. In a recent presentation by Anita Richardson, Associate Director for Policy Office of Compliance & Biologics Quality, she outlined four reasons for submitting a comprehensive 483 response, and eight suggestions for an effective response.

Four reasons for submitting a well-prepared and timely 483 response:

1. Could possibly mitigate an FDA compliance decision for further action (warning letter, etc.) “As a general rule, a Warning Letter should not be issued if the agency concludes that a firm’s corrective actions are adequate and that the violations that would have supported the letter have been corrected.”
2. Demonstrates to the FDA (and other stakeholders) an understanding and acknowledgement of the observations
3. Demonstrates to the FDA (and other stakeholders) a commitment to correct, i.e. the intent to voluntarily comply
4. Establishes credibility with FDA

Eight suggestions for an effective 483 response

1. Include a commitment/statement from senior leadership
2. Address each observation separately
3. Note whether you agree or disagree with the observation
4. Provide corrective action accomplished and/or planned; tell FDA the plan
   • Be specific (e.g. observation-by-observation)
   • Be complete
   • Be realistic
   • Be able to deliver what you promise
   • Address affected products
5. Provide time frames for correction
6. Provide method of verification and/or monitoring for corrections
7. Consider submitting documentation of corrections where reasonable & feasible
8. BE TIMELY

Good advice. And remember…

“A well-reasoned, complete, and timely 483 response is in your best interest.”