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

• FY 2010
• FY 2011
• FY 2012
• All

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 - 2011

Time	Target	Number
Oct 2010	N/A	536
Nov 2010	N/A	662
Dec 2010	N/A	692
Jan 2011	N/A	545
Feb 2011	N/A	632
Mar 2011	N/A	846
Apr 2011	N/A	705
May 2011	N/A	722
Jun 2011	N/A	782
Jul 2011	N/A	655
Aug 2011	N/A	800
Sep 2011	N/A	706

FY 2011 Total: 8,283

Total number of domestic mammography facility inspections completed during the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	538
Nov 2010	N/A	667
Dec 2010	N/A	695
Jan 2011	N/A	547
Feb 2011	N/A	635
Mar 2011	N/A	849
Apr 2011	N/A	708
May 2011	N/A	726
Jun 2011	N/A	786
Jul 2011	N/A	662
Aug 2011	N/A	805
Sep 2011	N/A	710

FY 2011 Total: 8,328