FDA 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 an FDA Warning Letter because you are in violation of important regulations. The Warning Letter is essentially a placeholder for civil or criminal remedies the FDA can pursue, 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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Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.
Physician- Entrepreneur- Consultant
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)