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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 March 31, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A17
Nov 2013N/A18
Dec 2013N/A26
Jan 2014N/A19
Feb 2014N/A6
Mar 2014N/A14
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 17

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

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A4
Nov 2013N/A4
Dec 2013N/A4
Jan 2014N/A4
Feb 2014N/A4
Mar 2014N/A4
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 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.