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U.S. Department of Health and Human Services

About FDA

Percent of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month (1)

Dictionary: Approximately 8,800 mammography facilities are inspected annually by FDA-certified MQSA inspectors (comprised of both FDA inspectors and State inspectors). MQSA inspections ensure that quality standards are met. Inspection findings are graduated from Level 1, 2, 3 to “no observation,” which reflects the degree of the facility’s violation from most serious to fully compliant, respectively.

A Level 1 finding represents a deviation from MQSA standards that may seriously compromise the quality of mammography services offered by the facility (i.e. sufficient objects in phantom image not visible). Gross adherence to MQSA standards is a valuable indicator of the efficacy of breast cancer diagnoses in the United States.

Information is current as of September 30, 2012

Fiscal Year - 2010

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TimeTargetPercent
Oct 2009N/A98.80
Nov 2009N/A99.48
Dec 2009N/A98.62
Jan 2010N/A98.94
Feb 2010N/A99.10
Mar 2010N/A98.89
Apr 2010N/A99.09
May 2010N/A99.13
Jun 2010N/A99.03
Jul 2010N/A99.26
Aug 2010N/A99.26
Sep 2010N/A99.22

FY 2010 Overall: 99.07%

Footnotes

  • (1) Level 1 inspection observations are considered the most serious - those that may have a detrimental effect on the quality of mammography services. An example is a facility that has mammography personnel who do not meet FDA’s minimum qualification standards. Level 1 violation require FDA to issue a warning letter; the facility must begin correcting problems immediately and respond in writing to FDA within 15 work days of receiving the warning letter about the corrective actions taken.

Number of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A741
Nov 2009N/A571
Dec 2009N/A644
Jan 2010N/A654
Feb 2010N/A551
Mar 2010N/A710
Apr 2010N/A765
May 2010N/A686
Jun 2010N/A718
Jul 2010N/A807
Aug 2010N/A675
Sep 2010N/A760

FY 2010 Total: 8,282

Total number of domestic mammography facility inspections completed during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A750
Nov 2009N/A574
Dec 2009N/A653
Jan 2010N/A661
Feb 2010N/A556
Mar 2010N/A718
Apr 2010N/A772
May 2010N/A692
Jun 2010N/A725
Jul 2010N/A813
Aug 2010N/A680
Sep 2010N/A766

FY 2010 Total: 8,360

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.