FDA Enforcement

The FDA can enforce their regulations in a variety of ways, including: 483s, untitled letters, warning letters, injunctions, delayed or no further approval of applications, corporate integrity agreements, disqualification or restriction of investigators, temporary or permanent debarment of firms or persons, and civil and criminal liability.

Your Response

In order to avoid these consequences, you must decide when and how to respond appropriately after an inspection.

Firstly, you do not have to respond. However, if you do, the FDA will be satisfied and will not intensify your inspection force or frequency, or resort to other actions described above.

If you respond, you must do so within 15 days. The response should be signed by the manager in charge who has the ability to enforce changes. The response should be addressed to the director of the FDA district office that conducted the inspection, and copies should be provided to the investigators who conducted the inspection, as well as any other probable interested FDA parties.

Do not overpromise and under-deliver. Understand that your entire quality system has a problem, and that you must avoid future problems and not just fix the problem that was found.

If You Agree

You must convince the FDA that you will soon be in compliance, and that you will remain in compliance. You must show that you understand the problem and that you are committed and have the resources to fix it.

First, determine the applicable law and what it requires. Then, perform a root cause analysis. Determine the root cause of the problem, why it occurred, and what steps must be taken to become and stay compliant from now on. Finally, develop a time frame in which the problem will be resolved, including milestones to track your progress and external verification if necessary. Make sure your senior management is committed to fixing the problem.

If You Disagree

If you believe the FDA made a mistake, you must convince the FDA that you are already in compliance. They may not have had all the facts, or some may have been disregarded. Certain factors may have been scientifically inaccurate, or there may have been a conflict in interpretation between the district office and headquarters.

Again, you must determine the applicable law and what it requires and perform a root cause analysis. Explain the FDA’s misinterpretation of the problem and, based on your analysis, provide evidence as to why it is not the problem. Describe your root cause analysis and provide any other available evidence to support your argument.

What Not to Include

In your response, do not anger the FDA by way of abusive statements or assertions against their credibility, technical knowledge, or competence.

Outside Help

You may need outside help responding to the enforcement action if you lack legal, regulatory, or clinical experience. You may also need help addressing the enforcement issues in a technical, legal, or regulatory manner if you are not comfortable doing so. Another instance that may require outside counsel is if the FDA expressed concerns about employees’ competence, motivation, or integrity.

For more information on this issue, contact the Kulkarni Law Firm.