FDA Consent Decree and DOJ Injunction
Avoid a halt in operations by meeting FDA regulations
A Consent Decree is the maximum enforcement action the FDA can take. It’s a serious step that can be devastating to your business now and in the future.
In order to get a Consent Decree, the FDA works with the Department of Justice (DOJ) to file a complaint against your business in Federal District Court. It’s important that your business responds to this kind of filing. Otherwise, a default judgement is entered against you. Most of the time, businesses do not fight the allegations, but settle the issue through a DOJ injunction.
Keep in mind that an FDA Consent Decree means that you have to completely halt your operations until the requirements are met.
Violations that can lead to a Consent Decree include labeling and misbranding or Good Manufacturing Practices (GMPs) violation. Your business will need to go through corrections and verifications audits before you can restart your operations.
Sometimes, a Consent Decree results in a recall of products, which can be wide in scope, covering long periods of time.
The best course of action for your business is to avoid a Consent Decree.
If you receive an FDA Warning Letter or Form 483, consult with a regulatory attorney right away. Proactive and timely responses to the FDA can mean your business doesn’t have to deal with a Consent Decree. FDA Atty specializes in all FDA legislation, and can help your business to avoid a complete halt in operations.
If you’ve already gotten a Consent Decree, keep in mind that you have options. We can help you negotiate the best possible outcome for your business, such as limiting the scope of the recall or expanding deadlines so you have more time to figure out your strategy.
When it comes to enforcement action by the FDA, time is ticking. Contact us today so we can start the process of getting your business in compliance with FDA regulation.
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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
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
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.
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)