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U.S. Department of Health and Human Services

About FDA

Number of domestic inspections completed in the quarter

Dictionary: FDA has expanded this measure in FY13 to track all domestic inspections, including those conducted at the state level. Once an inspection is complete, the FDA issues an inspection report with one of four actions: Official Action Indicated (OAI)1, Voluntary Action Indicated (VAI)2, No Action Indicated (NAI)3, or OTHER4. In each type of inspection report, FDA summarizes the findings of the facility inspection and indicates any manufacturing process improvements that are required or voluntary. 

Information is current as of November 19, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct – Dec 20137,5987,691
Jan – Mar 201411,39710,165
Apr – Jun 201411,39710,206
Jul – Sep 20147,5988,855

FY2014 Total: 36,917

Cumulative annual domestic inspections

Dictionary: Information is current as of November 19, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct – Dec 20137,5987,619
Jan – Mar 201418,99517,856
Apr – Jun 201430,39228,062
Jul – Sep 201437,99036,917

Cumulative percent of annual domestic inspections completed at the end of the quarter

Information is current as of November 19, 2014.

Fiscal Year - 2014
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TimeTargetCumulative Percent
Oct – Dec 20132020
Jan – Mar 20145047
Apr – Jun 20148074
Jul – Sep 201410097

Number of FDA funded attempted domestic inspections

Dictionary: Domestic inspections which were funded and attempted but unable to be completed. These inspections were not completed due to various reasons, some examples of why a washout occurs are: the firm is out of business, the firm is not located at the assigned location, the firm is not handling an FDA-regulated product, or the facility being inspected is not participating in interstate commerce.

Information is current as of November 19, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct – Dec 2013N/A941
Jan – Mar 2014N/A1,182
Apr – Jun 2014N/A1,248
Jul – Sep 2014N/A1,168

FY2014 YTD: 4,539

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.