FDA Consent Decree and DOJ Injunction

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.