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U.S. Department of Health and Human Services

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Average number of days from receipt of high priority inspection assignment to investigator initiating the inspection of inspections initiated that month

Dictionary: High priority inspection assignments are defined as: 1) Public health emergency (e.g., outbreak, trace-back), 2) User fee driven (e.g., PDUFA, MDUFMA), 3) For cause (e.g., follow-up to a compliance issue, complaint, adverse event), 4) Impending critical patent expiry, or 5) Special request

Information is current as of March 13, 2014.

Fiscal Year - 2013

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TimeTargetAverage number of days
Oct 2012N/A20
Nov 2012N/A23
Dec 2012N/A5
Jan 2013N/A28
Feb 2013N/A59
Mar 2013N/A39
Apr 2013N/A20
May 2013N/A49
Jun 2013N/A21
Jul 2013N/A31
Aug 2013N/A38
Sep 2013N/A60

Average number of days from investigator initiating the high priority inspection (entering the firm) to investigator completing the inspection of inspections completed that month

Dictionary: High priority inspection assignments are defined as: 1) Public health emergency (e.g., outbreak, trace-back), 2) User fee driven (e.g., PDUFA, MDUFMA), 3) For cause (e.g., follow-up to a compliance issue, complaint, adverse event), 4) Impending critical patent expiry, or 5) Special request

Information is current as of March 13, 2014.

Fiscal Year - 2013

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TimeTargetAverage number of days
Oct 2012N/A3
Nov 2012N/A4
Dec 2012N/A6
Jan 2013N/A5
Feb 2013N/A4
Mar 2013N/A3
Apr 2013N/A5
May 2013N/A6
Jun 2013N/A5
Jul 2013N/A6
Aug 2013N/A6
Sep 2013N/A4

Average number of days from investigator completing the high priority inspection to investigator submitting the report to headquarters of reports submitted that month

Dictionary: High priority inspection assignments are defined as: 1) Public health emergency (e.g., outbreak, trace-back), 2) User fee driven (e.g., PDUFA, MDUFMA), 3) For cause (e.g., follow-up to a compliance issue, complaint, adverse event), 4) Impending critical patent expiry, or 5) Special request

Information is current as of March 13, 2014.

Fiscal Year - 2013

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TimeTargetAverage number of days
Oct 2012N/A7
Nov 2012N/A6
Dec 2012N/A18
Jan 2013N/A29
Feb 2013N/A26
Mar 2013N/A14
Apr 2013N/A32
May 2013N/A7
Jun 2013N/A13
Jul 2013N/A14
Aug 2013N/A12
Sep 2013N/A13

Average number of days from investigator initiating the routine inspection (entering the firm) to investigator completing the inspection of inspections completed that month

Dictionary: Routine inspection assignments are defined as those that are received from the Centers as "surveillance" work at the beginning of the Fiscal Year

Information is current as of March 13, 2014.

Fiscal Year - 2013

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TimeTargetAverage number of days
Oct 2012N/A3
Nov 2012N/A4
Dec 2012N/A4
Jan 2013N/A4
Feb 2013N/A4
Mar 2013N/A5
Apr 2013N/A4
May 2013N/A4
Jun 2013N/A3
Jul 2013N/A4
Aug 2013N/A3
Sep 2013N/A3

Average number of days from investigator completing the routine inspection to investigator submitting the report to headquarters of reports submitted that month

Dictionary: Routine inspection assignments are defined as those that are received from the Centers as "surveillance" work at the beginning of the Fiscal Year

Information is current as of March 13, 2014.

Fiscal Year - 2013

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TimeTargetAverage number of days
Oct 2012N/A5
Nov 2012N/A18
Dec 2012N/A14
Jan 2013N/A22
Feb 2013N/A19
Mar 2013N/A14
Apr 2013N/A16
May 2013N/A14
Jun 2013N/A12
Jul 2013N/A20
Aug 2013N/A17
Sep 2013N/A8

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.