The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main actions[1]:

  • Warning Letters
  • Seizure
  • Injunction
  • Criminal Prosecution

It should be noted that there is a difference between a Warning Letter and a 483 Letter, another type of letter the FDA may issue a company.

There are many reasons why enforcement actions may be taken. Anything from having a poorly made Quality Management System to selling a product without the proper approval may trigger the FDA to take action. Even if everything within a company may seem fine a company should have a strategy in place to deal with the actions should one be taken against them.

Warning letters and 483’s are the less severe of the 4 actions. Warning letters detail violations that FDA noticed and require a response by the company within a specified time frame.[1]

Injunctions and criminal prosecution are the more severe actions. Injunctions are taken to stop corporations from committing certain acts.1 What that act actually is will vary depending on the situation. It could range from requiring the stop of product and sell of a specific product or it could require the stop of all operations at a facility until the problem can be fixed. Criminal prosecution is the most severe of the actions and can result in imprisonment of 1-3 years depending on the violation.[1]

Enforcement actions are scary, to say the least. In many cases, the actions gradually increase in severity from 483’s on. This might not always be the case, however. It is better to ensure that everything is in order so that no enforcement action is used than to wait for one to be issued. Should one be taken, a company should have a plan in place to deal with it. EMMA International can help prepare a strategy for dealing with enforcement actions should the need arise. If the need does arise, EMMA International can help implement the strategy as well, even acting as a liaison between your company and the FDA. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (November 2017) Types of FDA Enforcement Actions, Retrieved 02/05/2022 from https://www.fda.gov/animal-veterinary/resources-you/types-fda-enforcement-actions

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Ready to learn more about working with us?

Pin It on Pinterest

Share This