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U.S. Department of Health and Human Services

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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 - 2012

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TimeTargetNumber
Oct 2011N/A8
Nov 2011N/A4
Dec 2011N/A2
Jan 2012N/A10
Feb 2012N/A5
Mar 2012N/A12
Apr 2012N/A3
May 2012N/A6
Jun 2012N/A6
Jul 2012N/A3
Aug 2012N/A7
Sep 2012N/A9

FY 2012 Total: 75

Number of warning letters reviews completed during the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A9
Nov 2011N/A4
Dec 2011N/A2
Jan 2012N/A4
Feb 2012N/A5
Mar 2012N/A7
Apr 2012N/A12
May 2012N/A5
Jun 2012N/A6
Jul 2012N/A2
Aug 2012N/A5
Sep 2012N/A11

FY 2012 Total: 72

No submeasures applicable for this time period.

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

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A4
Nov 2011N/A4
Dec 2011N/A4
Jan 2012N/A10
Feb 2012N/A10
Mar 2012N/A15
Apr 2012N/A6
May 2012N/A7
Jun 2012N/A7
Jul 2012N/A8
Aug 2012N/A10
Sep 2012N/A8

FY 2012 Overall: 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.