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U.S. Department of Health and Human Services

About FDA

Number of warning letters received

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 December 31, 2014

Fiscal Year - 2015

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TimeTargetNumber
Oct - Dec 2014N/A38
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 38

Number of warning letters reviews completed during the month

Fiscal Year - 2015

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TimeTargetNumber
Oct - Dec 2014N/A22
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 22

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

Fiscal Year - 2015
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TimeTargetNumber
Oct - Dec 2014N/A16
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 16

Percentage of warning letters completed within 15 working days

Fiscal Year - 2015
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TimePercentageNumber
Oct - Dec 20145042%
Jan - Mar 201550TBD
Apr - Jun 201550TBD
Jul - Sept 201550TBD

FY 2015 YTD: 42%

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

Fiscal Year - 2015

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TimeTargetNumber
Oct - Dec 2014N/A30
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 30

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.