How NOT To Respond To An FDA Warning Letter
By Joseph Pickett, president, ExpertBriefings.com
Has your company received an FDA warning letter? A proper response is critical and may mean the difference between whether the FDA accepts your response or determines that additional action is required. When crafting your response, make sure you do not make a bad situation worse by engaging in any of these mistakes.
1. Do not give a late response
Probably the worst mistake you can make when responding to a 483 or warning letter is to send in your response late. Remember that you now have only 15 days to respond to the FDA. If you send a response later than 15 days from when you got the letter, your response is not going to be opened or read. Some firms will spend $40,000 on a consultant to formulate a response and plan of action, and then send it in late. If they do, it won’t be looked at, and they will have wasted their money.
2. Never pass the buck
In the response, take responsibility for any exceptions noted. You will also need to designate appropriate individuals in the organization to take responsibility for each relevant warning letter observation. Do not attempt to blame personnel who left the company. It’s your company’s job to make sure that FDA cGMP compliance is assured regardless of whether there is employee turnover. The FDA doesn’t want to know who was to blame. They want to know what you are going to do to make sure it doesn’t happen again.
3. Do not scapegoat other companies
Your warning letter response is not the forum to throw darts at other companies in your industry. Comparing your company to another firm that supposedly has worse problems is not going to win you any new friends at the FDA. It may actually cause you more trouble.
4. Make sure you properly identify the causes of cGMP violations
You will have time to investigate the issues, so make sure you figure out the cause of the problems. Resist the urge to place the blame on improper training. That happens to be the most convenient answer but not always the correct one. Spend time looking at your internal processes and systems and really learn what the root cause is. The FDA will want to know that you’re not just fixing the problem in this area, but will ensure that it does not happen is other areas as well.
5. Don’t skimp on documentation
The agency will want to see full documentation of any changes you claim to be making in your quality systems. If you do not fully address each item on the warning letter and do not fully document your solutions, the FDA will not be satisfied with the response and is going to have to take a closer look. Make sure your response is concise and provides enough detail to show that you are aware of the causes of the problem and are taking the correct and appropriate steps to address them.
6. Don’t provide unnecessary documentation
While you want to fully document your solutions, do not try to filibuster your way to getting the FDA to leave you alone. Do not provide long, rambling warning letter responses. Rambling on about the cause of a problem is not going to satisfy the FDA. Write a complete and detailed answer, but don’t bloviate.
7. Don’t delegate your warning letter response to the interns
A warning letter from FDA is titled to the head of the company for a reason. cGMP violations are important, and FDA expects that top senior level management is going to review and answer the warning letter. Make sure those individuals are addressing the issues and preparing the response.