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 to get in touch with our team of experts today.

[1] FDA (November 2017) Types of FDA Enforcement Actions, Retrieved 02/05/2022 from

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

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This