FDA Recalls

Learn how you can get back to business if your product has been recalled

fda recall

Learning your product has been recalled by the FDA can be devastating for a business. Not only is your revenue at risk — but so is your reputation.

The best course of action is to avoid being in a situation where your product is recalled. This means that you need to abide by FDA regulations and provide the Agency with the right information about your products. 

FDA Atty has over a decade of experience helping businesses ensure compliance with FDA regulations. We assist with label reviews, advertising reviews, import and export forms, and much more. We provide guidance on what language to use on forms, packaging, and marketing, in order to reduce the risk of a recall.

If you’ve received a product complaint or report of an injury or illness, your business is obligated to report it to the FDA. In this case, you need a rapid response strategy so you can get ahead of the issue and avoid a recall. 

FDA Atty has extensive experience managing all aspects of a recall or adverse event and illness reporting.

Don’t let a recall throw your business off track. Get in touch today to discuss how FDA Atty can help you get back in compliance.

Don’t let a recall throw your business off track. Get in touch today to discuss how FDA Atty can help you get back in compliance. 

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“

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.

Joel Kleinman

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.

Angela Fusaro

Physician- Entrepreneur- Consultant

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)

Rapid Release

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

Helpful Resources

FDA Enforcement and Recall Report Week of July 4

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FDA Enforcement and Recall Report Week of June 23

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FDA Enforcement and Recall Report Week of June 13

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