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U.S. Department of Health and Human Services

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, 2015.

Fiscal Year - 2012

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Oct 2011N/A2
Nov 2011N/A3
Dec 2011N/A3
Jan 2012N/A1
Feb 2012N/A0
Mar 2012N/A1
Apr 2012N/A3
May 2012N/A1
Jun 2012N/A0
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A0

FY 2012 Total: 14


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.