Legally, you don’t have to respond to FDA 483 observations. But practically, you should; it’s in your best interest to respond quickly and in writing. A well prepared 483 response demonstrates to FDA and other stakeholders that you understand the observations and are committed to correcting them. It also can help mitigate further FDA action such as a Warning Letter.
Here are 8 tips from EduQuest’s experienced team of auditors who have been on both sides of FDA 483 observations — writing them as FDA investigators and responding to them as quality managers and advisors to medical device and pharmaceutical companies:
- Include a commitment statement from your senior leadership
- Address each 483 observation separately
- Note whether you agree or disagree with the observation
- Describe the corrective actions you’ve already done or plan to do..and share your plan with FDA
- Outline your schedule for making corrections
- Tell FDA how you will verify or monitor the corrections
- Consider providing documentation of your corrections, when reasonable and feasible
- BE TIMELY with your response
For more information on preparing for and handling FDA inspections, attend EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance class.