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Percentage of Tissue Residue and Unapproved Drug Warning Letters Recommendation package reviews with Center recommendations within 25 days

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, 2020.

Fiscal Year - 2020

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TimeTargetPercentage
Oct - Dec 2019500
Jan - Mar 2020500
Apr - Jun 20205050
Jul - Sept 2020N/ATBD

FY 2020 Target: 50% YTD: 11%

Number of Tissue Residue and Unapproved Drug warning letters reviews completed within 25 working days

Fiscal Year - 2020
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TimeTargetNumber
Oct - Dec 2019N/A0
Jan - Mar 2020N/A0
Apr - Jun 2020N/A2
Jul - Sept 2020N/ATBD

FY 2020 YTD: 2

Number of Tissue Residue and Unapproved Drug warning letters reviews completed

Fiscal Year - 2020
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TimeTargetNumber
Oct - Dec 2019N/A12
Jan - Mar 2020N/A2
Apr - Jun 2020N/A4
Jul - Sept 2020N/ATBD

FY 2020 YTD: 18

Number of Tissue Residue and Unapproved Drug warning letters received

Fiscal Year - 2020
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TimeTargetNumber
Oct - Dec 2019N/A13
Jan - Mar 2020N/A4
Apr - Jun 2020N/A3
Jul - Sept 2020N/ATBD

FY 2020 YTD: 20

Number of Tissue Residue and Unapproved Drug warning letters pending

Fiscal Year - 2020
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TimeTargetNumber
Oct - Dec 2019N/A1
Jan - Mar 2020N/A3
Apr - Jun 2020N/A1
Jul - Sept 2020N/ATBD

FY 2020 YTD: 1

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.

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