About FDA

Average number of days from receipt of high priority inspection assignment to investigator initiating the inspection

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 February 12, 2013.

• FY 2012
• FY 2013
• All

Footnotes

• Measure tracked in calendar days

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

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

Footnotes

• Measure tracked in calendar days

Average number of days from investigator completing the high priority inspection to investigator submitting the report to headquarters

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

Footnotes

• Measure tracked in calendar days

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

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

Footnotes

• Measure tracked in calendar days

Average number of days from investigator completing the routine inspection to investigator submitting the report to headquarters

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

Footnotes

• Measure tracked in calendar days