5 Critical Tips to Solve An FDA Warning Letter Crisis

5 Critical Tips to Solve An FDA Warning Letter Crisis

September 11th, 2013 // 9:29 pm @

Every year, FDA sends out hundreds of warning letters to drug and device companies for cGMP and quality system regulation violations. Some of the violations are for manufacturing violations and some are due to misbranding and mislabeling. Firms that respond effectively to an FDA warning letter are getting a step ahead of the game. Addressing the warning letter in a very clear and fast fashion will help you to get back into the good graces of FDA. But woe be to the company that does not address the warning letter properly! Below are five crucial tips to remember as you deal with FDA and the warning letter:

#1 Do Not Ignore Your Warning Letter

Be certain that you fully understand what you are being cited for. Within one day, call FDA to discuss all of the issues in the letter. Advise the agency that you got the letter and that your team is putting together a plan to deal with the problems.

#2 Assign the Top Leadership to Deal with Your Warning Letter

Let’s face it: An FDA warning letter is the equivalent of a 5 alarm fire. It’s a crisis. That is why you need to carefully ID people in your organization who are the strongest project managers to lead the response to the agency. You really want your best and brightest consensus builders and leaders leading this project. Be aware of those who may have been in part responsible for some of the citations listed in the 483 and warning letter. Quickly determine if you have the staff in house to deal with the problems. If not, look for a good independent consultant outside your company to deal with your warning letter issues.

#3 Break Down the Warning Letter Into Projects

Use your CAPA system to manage each separate warning letter item until each matter is closed. FDA is going to want to know if you are using your Corrective and Preventive Action system and that it is working right. Getting that warning letter surely shows there are issues that have to be fixed. Your CAPA system works like the immune system. When it is working right, your company will answer FDA in a good way – with better quality systems.

#4 Assign the Top Team Members to Every CAPA

If your warning letter is highly detailed, you should have a point person to oversee the whole letter. Go over each FDA finding to see if your CAPAs are going to address the root cause, and figure out a time frame to implement all corrective actions. You need to address the warning letter within 15 days.

#5 Deal With FDA Through the Whole Process

Communicate regular and issue status reports to FDA. Follow through on all your promises. You know you are going in the right direction with the agency when you get strong positive communication from them. Stay on top of any and all communication with FDA.


Subscribe Now

Featured Partner