Warning Letters

Find out what to do if you receive a notice of a serious violation so you can act quickly

If the FDA has sent your business a Warning Letter, you could be in trouble if you don’t respond right away. While it can cause a lot of anxiety, you can get back to business if you respond properly with the help of an expert.

Your business has received a Warning Letter because you are in violation of important FDA regulations. The Warning Letter is essentially a placeholder for civil or criminal remedies the FDA can purse, such as recalls, seizures, and injunctions. With only 15 days to respond, it’s critical to act now.

With over 10 years of experience assisting clients with responding to FDA Warning Letters and other enforcements, we can ensure your business gets on the right side of the FDA again.

In your response, it’s critical to include the plan you’re going to put into place in order to correct the issues the FDA has identified. You’ll also have to include a detailed response for each allegation they have identified.

Sometimes, the FDA requires businesses who have received Warning Letters to hire a consultant to help with the resolution. Even if it’s not mandatory, completing this voluntary action shows the FDA how committed you are to getting back in compliance. You’ll need to be familiar with the regulations in Part 21 of the CFR, and how they apply to your business. It’s always best to get an expert opinion in order to prepare your response.

The key is to respond as quickly as possible. 

Contact FDA Atty so we can assist you in your response, ensuring you can resume operations before you get another penalty. 

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