About FDA

Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to environmental positive findings (subset of enforcement actions)

Dictionary: This measure captures the number of product recalls due to environmental contamination in the manufacturing, storage, or transit facilities that result when current good manufacturing practices (cGMPS) are not followed. cGMPs ensure that FDA regulated products are manufactured under safe and sanitary conditions. Environmental controls are part of an overall approach to cGMPS.

Warning Letter: A letter notifying a regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes.

Injunction: An order issued by the Court requiring a defendant to perform an act which he is obligated to perform but refuses to do, or forbidding him from doing a specified act which he is threatening or attempting to do.

Seizure: Attachment of goods through Court order by a U.S. Marshal pursuant to Section 304 of the FD&C Act.

• Lot-specific seizure: Seizure of all units in a specific lot or batch of a product.
• Open-ended seizure: Seizure of all units of a specific product, regardless of lot or batch.
• Mass seizure: Seizure of all products and equipment at an establishment/facility.
• Multiple seizures: Seizure of the same product in more than one district court.

Information is current as of March 31, 2023.