How to Respond to An FDA Warning Letter
Oct. 3, 2017
An FDA warning letter is essentially the equivalent of a “cease and desist.” If you've received a warning letter from the FDA, chances are something about your product hasn't met FDA standards and they're offering you the opportunity to make some necessary changes before your product is pulled from the market. Being issued a warning letter is stressful, but when you take the right steps, it can be far from detrimental.
Identify What Issues the FDA Has with Your Product
An FDA warning letter gives detail about alleged violations your company has made regarding your product(s), your marketing, your product label(s), etc. The first step to handling a warning letter is to break it down and determine what exactly your alleged violations were.
Determine What Needs to Change to Meet FDA Regulations
Sooner rather than later, you'll need to hold a meeting with any key players in your business to determine what might need to change about the design or manufacture of your product, the marketing of your product, or anything else the FDA stated was violated in the warning letter. Some of these things could be simple changes like updating a label, while others could take time and resources. You'll need to have an idea of exactly what it will take to meet regulations.
Write a Response to The Warning Letter
Once you've identified what you plan to do to satisfy the requirements set forth by the FDA, you'll need to craft a well-thought-out response. Generally speaking, the more comprehensive the response, the more you'll illustrate that your company is taking the FDA's concerns seriously.
You want to avoid being confrontational in the letter and be sure to address each point of contention with an appropriate response about what you plan to change, how long it will take, and what additional steps you may be taking to resolve the issue. Often, a warning letter response requires the help of an experienced FDA lawyer.
Be Ready for A Follow-Up
Be prepared for a follow-up inspection by the FDA to ensure that you have indeed made the changes necessary to meet FDA regulations. Stick to the time frame you provided to them in your response and make sure to have any and all changes completed by that time.
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