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U.S. Department of Health and Human Services

About FDA

Average number of business days for CVM to complete the review of warning letters from ORA districts

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/A34
Nov 2012N/A19
Dec 2012N/A20
Jan 2013N/A25
Feb 2013N/A37
Mar 2013N/A14
Apr 2013N/A10
May 2013N/A7
Jun 2013N/A27
Jul 2013N/A14
Aug 2013N/A6
Sep 2013N/A12

FY 2013 Overall: 19

Number of OSC full time employees reviewing warning letters at the end of the month

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A4
Nov 2012N/A4
Dec 2012N/A4
Jan 2013N/A4
Feb 2013N/A4
Mar 2013N/A4
Apr 2013N/A4
May 2013N/A4
Jun 2013N/A4
Jul 2013N/A4
Aug 2013N/A4
Sep 2013N/A4

FY 2013 Overall: 4

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.