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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, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A2
Dec 2013N/A0
Jan 2014N/A2
Feb 2014N/A1
Mar 2014N/A3
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 8

Glossary

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.