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U.S. Department of Health and Human Services

About FDA

Number of warning letters received from ORA districts during the month

Dictionary: CVM’s warning letter review ensures that the issued warning letter clearly follows the Agency’s rules, regulations and policies for the animal food/drug/device/biologics regulated industry and that these rules, regulations and policies are being implemented equally across all of the ORA district’s and internationally. Warning Letters are the Agency’s principal means of notifying the regulated industry of violations and achieving prompt voluntary correction. Warning letters need be issued soon after an inspection so the regulated industry is notified of their non-compliance. The regulated industry can then quickly implement corrective actions in order to become compliant with FDA’s rules, regulations and policies.

Information is current as of June 30, 2014

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A12
Nov 2012N/A12
Dec 2012N/A10
Jan 2013N/A3
Feb 2013N/A11
Mar 2013N/A9
Apr 2013N/A4
May 2013N/A16
Jun 2013N/A6
Jul 2013N/A7
Aug 2013N/A13
Sep 2013N/A12

FY 2013 Total: 115

Number of warning letters reviews completed during the month

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A7
Nov 2012N/A10
Dec 2012N/A14
Jan 2013N/A6
Feb 2013N/A10
Mar 2013N/A12
Apr 2013N/A8
May 2013N/A5
Jun 2013N/A12
Jul 2013N/A13
Aug 2013N/A5
Sep 2013N/A13

FY 2013 Total: 115

Number of warning letters review completed within 15 working days during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A5
Nov 2012N/A5
Dec 2012N/A6
Jan 2013N/A1
Feb 2013N/A5
Mar 2013N/A10
Apr 2013N/A6
May 2013N/A5
Jun 2013N/A5
Jul 2013N/A8
Aug 2013N/A5
Sep 2013N/A8

FY 2013 Total: 69

Number of pending warning letters to be reviewed by CVM at the end of the month

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A13
Nov 2012N/A15
Dec 2012N/A11
Jan 2013N/A8
Feb 2013N/A9
Mar 2013N/A6
Apr 2013N/A2
May 2013N/A13
Jun 2013N/A7
Jul 2013N/A1
Aug 2013N/A9
Sep 2013N/A8

FY 2013 Overal: 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.