5 Crucial Tips to Deal With an FDA Warning Letter

5 Crucial Tips to Deal With an FDA Warning Letter

April 18th, 2013 // 12:54 am @

Updated Daily – Read our latest FDA, cGMP Compliance News

April 17, 2013

Every year, FDA hands out several hundred warning letters to pharmaceutical and medical device firms for cGMP guideline violations. Companies that respond effectively to the warning letter can get back in the good graces of FDA and develop quality control processes that can end up helping the business. But if you do not address the warning letter properly, you can find yourself in a lot of trouble.

May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters

Here are five simple tips to keep in mind while you are working with FDA on the issues in the letter, and also how to adapt your business practices so you are more in compliance with cGMPs:

  1. Never ignore a warning letter. Once you receive the letter, be certain that you are very clear on what your company has done wrong. You should call FDA within 24 hours to discuss all cGMP violations. Advise FDA that you have gotten the letter and that you are working with your team to put in place  plan to address all violations.
  2. Decide very carefully on the leadership that will handle the issues in the letter. You should pinpoint strong senior managers who are good at managing projects. These are the best people to handle the response to the agency. These people should be your best and brightest and should be good at growing consensus pertaining to all warning letter items. Be aware of the people who might have been responsible for the 483 observations and the warning letter. Figure out if you have the type of expertise in your company to handle the problems. If not, you should consider getting a consultant to help you address the issues.
  3. After you decide on the warning letter team, you should break down the issues in the letter into several projects. Use your CAPA system to manage each project until successful completion. FDA wants to see that you are using a strong CAPA system. If you have an FDA warning letter, you definitely have some systemic problems that you ahve to fix. If your CAPA system is working well, it is somewhat akin to your body’s immune system. When it is working right, your business will respond to the letter in a good way and you will have improved quality systems that helps to improve the bottom line.
  4. Assign your best team members to every CAPA. If the warning letter is complicated, you should have a point person to handle all of the issues in the letter. Go over every finding and make sure CAPAs will deal with the root cause. Figure out a good time frame to implement every CAPA. Make sure you have sent a response to FDA within 15 working days. Give them a detailed timeline on your plan to deal with all problems.
  5. Talk to FDA all through the warning letter process and give them regular reports. Follow through on every promise you make. You will know you are headed in the right direction when you get positive communication from FDA.

Our upcoming Webinar with the former FDA Chief Counsel, Sheldon Bradshaw, will provide you with some very unique insights into the FDA warning letter process.

Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:

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