How to Handle An FDA Warning Letter
April 13th, 2022 // 5:56 pm @ jmpickett
Did your company receive an FDA warning letter, possibly including cGMP violations? If so, there are vital steps you can take to reduce the effects of the warning letter.
The warning letter will be issued if there is a deficiency or violation in your pharmaceutical or medical device operations. These letters tell you that your FDA-regulated product has a severe violation that requires you to take immediate action.
The warning letters are issued publicly so can create a lot of issues for your organization. If you don’t respond quickly to an FDA warning letter, there can be civil fines, injections, product seizures, product recalls, and more. Occasionally, serious FDA violations that involve recklessness, there can even be criminal prosecution.
If you receive an FDA warning letter, you only will have a few weeks to respond. That’s why you may want to retain an FDA lawyer to help you better grasp the violations and know what to do.
FDA Warning Letter Structure
Most FDA warning letters have a similar structure. The letter will detail the product in question, your address and contact information, and the office from which the letter was issued.
The letter always states the major regulation that was violated, often the FD&C Act. The letter will provide details about the violation and what you should do. Common reasons for FDA warning letters are:
Flawed design or flawed design process
Not having a marketing authorization from FDA
Not following correct manufacturing processes
False labeling
Inadequate monitoring system
Misbranded products
Not enough scientific research
Making medical claims for an unapproved product
The letter also states the corrective action you need to do and when you have to make the changes. It also notes the consequences if you don’t act. Usually, you need to provide a written response within 15 days that show the steps you will take to fix the issues.
For example, you may need to provide the steps you are taking to make your operations or products come into to full FDA compliance. Or, you should provide the plan for ensuring full compliance on a regular basis.
What To Do After A Warning Letter
There are several ways to address the FDA matter fast and reduce company exposure. You first should bring in an FDA attorney who has success handling warning letters. The lawyer will help you find out what FDA is stating and how to effectively respond. Doing these things fast will help get out of an investigation, criminal charges, or liability.
If you get a warning letter from FDA, get qualified legal help as soon as you can. An FDA warning letter can cause several problems and even criminal liability.
