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U.S. Department of Health and Human Services

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Number of product manufacturing facilities site inspections which occurred during the month

Dictionary: Number of OBP product manufacturing facilities site inspections which occurred during the month. OBP review staff participates in most pre-approval inspections and many surveillance inspections of manufacturing facilities. For complex products, such as therapeutic protein and monoclonal antibody products, it is important for OBP reviewers to participate in the assessment of the manufacturing process and controls at the facility.


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 - 2012

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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A0
Dec 2011N/A1
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 3

Number of pre-, post-, and during inspection meetings which occurred during the month

Dictionary: Number of pre-, post-, and during inspection meetings with ORA and CDER’s Office of Compliance (OC) Division of Manufacturing and Product Quality (DMPQ) which occurred during the month. For complex products, such as therapeutic protein and monoclonal antibody products, it is important for OBP reviewers to participate in the assessment of the manufacturing process and controls at the facility. This participation involves meetings. In addition, for facilities where OBP does not participate in the inspection, meetings convey issues to be considered during inspections.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A1
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 1

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.