If you are reading this you are probably in the middle of an enforcement crisis. Responding to an FDA-483, Warning Letter, or in some cases, a product seizure or injunction can be one of the most important, and most challenging, activities in your company’s history. Failing to ensure a proper response and failing to satisfy the FDA can be dangerous, if not fatal, to your business.
There are Dos and Don’ts in responding to the FDA:
- Unless you are an expert in FDA 483 responses, get an expert in FDA response preparation to assist you;
- Respond within 14 calendar days (10 business days) regardless of whether you are completely ready to respond or not;
- NOTE: The FDA has enacted a new policy that it will issue automatic Warning Letters to companies that fail to respond to FDA 483s within 15 days.
- Strike the right tone in your communications – be sensitive to admissions of noncompliance;
- Offer a complete, thorough and compelling remediation plan, which identifies and re-mediates the root cause of the deficiency;
- At least notify FDA counsel of the situation, and preferably, ensure all communications with the FDA are reviewed by outside counsel.
- Complain about how the FDA is singling you out;
- Be late with your response. It does not matter how busy you are — you must get the response in timely;
- Challenge the FDA’s interpretation of the law or regulation unless you’ve obtained expert counsel;
- Assume that you are out of the woods because you haven’t heard back from the FDA on your response. You should be undergoing a comprehensive compliance assessment to ensure that when they do walk back in your door — and they will — that you will present a world-class quality and compliance operation that will fully meet their expectations.
When in doubt about how to respond seek out an expert’s advice.
Leave a comment