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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 August 20, 2014.

Fiscal Year - 2013

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TimeTargetNumber
Oct – Dec 20128,0268,091
Jan – Mar 201312,03810,957
Apr – Jun 201312,03810,315
Jul – Sep 20138,0268,486

Cumulative annual domestic inspections

Dictionary: Information is current as of August 20, 2014.

Fiscal Year - 2013

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TimeTargetNumber
Oct – Dec 20128,0268,091
Jan – Mar 201320,06419,048
Apr – Jun 201332,10229,363
Jul – Sep 201340,12837,849

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

Information is current as of August 20, 2014.

Fiscal Year - 2013
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TimeTargetCumulative Percent
Oct – Dec 20122020
Jan – Mar 20135047
Apr – Jun 20138073
Jul – Sep 201310094

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 August 20, 2014.

Fiscal Year - 2013

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TimeTargetNumber
Oct – Dec 2012N/A1,844
Jan – Mar 2013N/A1,681
Apr – Jun 2013N/A1,687
Jul – Sep 2013N/A1,236

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.