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U.S. Department of Health and Human Services

About FDA

Total number of Warning Letters recommendations reviewed in the month

Dictionary: The Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.


These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A53
Dec 2009N/A13
Jan 2010N/A10
Feb 2010N/A12
Mar 2010N/A17
Apr 2010N/A14
May 2010N/A12
Jun 2010N/A10
Jul 2010N/A8
Aug 2010N/A14
Sep 2010N/A9

Number of Seizure actions reviewed in the month

Dictionary: The Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A0
Dec 2009N/A0
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A1
Apr 2010N/A0
May 2010N/A0
Jun 2010N/A0
Jul 2010N/A1
Aug 2010N/A1
Sep 2010N/A0

Number of Disqualifications reviewed in the month

Dictionary: The Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A1
Nov 2009N/A0
Dec 2009N/A1
Jan 2010N/A0
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A1
May 2010N/A0
Jun 2010N/A1
Jul 2010N/A0
Aug 2010N/A1
Sep 2010N/A0

Number of Injunction packages reviewed in the month

Dictionary: The Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.

Fiscal Year - 2010

Skip graphic and jump to text data

TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A0
Dec 2009N/A0
Jan 2010N/A0
Feb 2010N/A1
Mar 2010N/A3
Apr 2010N/A2
May 2010N/A0
Jun 2010N/A1
Jul 2010N/A0
Aug 2010N/A1
Sep 2010N/A1

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.