• Decrease
  • Normal
  • Increase
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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A12
Nov 2010N/A12
Dec 2010N/A16
Jan 2011N/A9
Feb 2011N/A16
Mar 2011N/A14
Apr 2011N/A5
May 2011N/A19
Jun 2011N/A20
Jul 2011N/A10
Aug 2011N/A17
Sep 2011N/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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A3
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A0
Apr 2011N/A1
May 2011N/A1
Jun 2011N/A2
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A1
Feb 2011N/A0
Mar 2011N/A1
Apr 2011N/A0
May 2011N/A1
Jun 2011N/A0
Jul 2011N/A1
Aug 2011N/A0
Sep 2011N/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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A1
Feb 2011N/A0
Mar 2011N/A1
Apr 2011N/A1
May 2011N/A0
Jun 2011N/A0
Jul 2011N/A0
Aug 2011N/A1
Sep 2011N/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.