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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 - 2012

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TimeTargetPercent
Oct 2011N/A98.80
Nov 2011N/A98.97
Dec 2011N/A99.14
Jan 2012N/A99.33
Feb 2012N/A99.27
Mar 2012N/A99.10
Apr 2012N/A99.25
May 2012N/A99.17
Jun 2012N/A99.16
Jul 2012N/A99.26
Aug 2012N/A99.09
Sep 2012N/A99.33

FY 2012 Overall: 99.16%

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 - 2012
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TimeTargetNumber
Oct 2011N/A493
Nov 2011N/A675
Dec 2011N/A691
Jan 2012N/A594
Feb 2012N/A682
Mar 2012N/A768
Apr 2012N/A658
May 2012N/A717
Jun 2012N/A827
Jul 2012N/A674
Aug 2012N/A761
Sep 2012N/A744

FY 2012 Total: 8,284

Total number of domestic mammography facility inspections completed during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A499
Nov 2011N/A682
Dec 2011N/A697
Jan 2012N/A598
Feb 2012N/A687
Mar 2012N/A775
Apr 2012N/A663
May 2012N/A723
Jun 2012N/A834
Jul 2012N/A679
Aug 2012N/A768
Sep 2012N/A749

FY 2012 Total: 8,354

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.