Compliance Actions

Caveats:

  • Certain information in these datasets may not be presented or may have changed since the posting. The datasets are updated weekly and only include final actions. If you need to present more recent or more complete data for official purposes or have questions about obtaining other data, please contact the Division of Freedom of Information about what materials may be available in electronic reading rooms or inquire about other datasets that would satisfy your needs.
  • Compliance data provide information on a subset of the actions used by the FDA to bring firms into compliance, specifically data pertaining to Warning Letters, Seizures, and Injunctions. Other actions such as Untitled Letters, Administrative Actions, and Regulatory Meetings are used by the FDA to bring firms into compliance but are not provided in the Dashboard data. For more information on these and other actions please reference the Regulatory Procedures Manual.
  • The compliance actions disclosed include only finalized and completed actions and are primarily used in the domestic arena. Actions pertaining to foreign firms often take the form of import alerts.
  • More than one establishment may be associated with one compliance action. The counts provided in this section reflect the number of establishments linked to the compliance action.
  • For more information regarding the Center for Tobacco Products (CTP) issued warning letters click here.

Actions by Product Type:

Biologics
Devices
Drugs
Food / Cosmetics
Tobacco
Veterinary
All Actions *

* Cases associated with multiple product types will be counted once for each product type. In those situations, the values for All Actions by product type may differ from All Actions by compliance action type.

Domestic Actions
Foreign Actions

Compliance Actions

Total:

  • Some actions are counted as both domestic and foreign when there are both domestic and foreign firms associated with the action.
  • The total count in the map is based on distinct actions (Case/Injunction IDs) and may be different from the total count displayed above the data table. Data table includes all records pertaining to each Case/Injunction ID.
  • To view actions associated with a specific state, use the Firm State filter selector.
Number of Compliance Actions
  • 0

Compliance Actions Details