Inspections, Compliance, Enforcement, and Criminal Investigations
The Women's Imaging Center 10-Mar-06
Department of Health and Human Services
Public Health Service
Southwest Regional Office
March 10, 2006
Via Federal Express - Next Day
Re: MQSA Inspection ID # 216440
Kelly McAleese, M.D.
The Women's Imaging Center
3773 Cherry Creek N . Dr. Suite 101
Denver, CO 80209
Dear Dr. McAleese,
On November 4, 2005 and November 29, 2005, representatives of the Food and Drug Administration (FDA) conducted an inspection at your facility which revealed a serious problem involving the conduct of mammography. Under the Mammography Quality Standards Act of 1992 ("MQSA") which is codified in Section 263b of Title 42 of the United States Code (USC), you must meet specific requirements to practice mammography. These requirements serve to protect the health of women by assuring that a facility can perform quality mammography.
The inspection revealed violations of the MQSA. These violations were noted on the MQSA Facility Inspection Report that the inspector provided to you on November 4, 2005 and January 12, 2006. The violations are again identified below.
Level 1: Mammograms were processed in processor 02, Kodak, X-OMAT M35 or M35A-M, located in Darkroom at The Women's Imaging Center, when it was out of limits on at least 5 days. [See 21 CFR 900.12(e)(1)].
Level 1: Mammograms were processed in processor, Primary, Kodak, Other, located in Darkroom at The Women's Imaging Center, when it was out of limits on at least 5 days . [See 21 CFR 900.12(e)(1)].
Level 2: Corrective actions for processor QC failures were not documented at least once for processor 02, Kodak, X-OMAT M35 or M35A-M, located in Darkroom at The Women's Imaging Center. [See CFR 900.12(e)(1)].
Level 2: Corrective actions for processor QC failures were not documented at least once for processor, Primary, Kodak, Other, located in Darkroom at The Women's Imaging Center. [See CFR 900.12(e)(1)].
On November 30, 2005, you responded by letter to the noncompliances found during the inspection as referenced in this Warning Letter. The corrective actions you have implemented will be evaluated during your next inspection.
Because these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:
requiring your facility to undergo an Additional Mammography Review
placing your facility under a Directed Plan of Correction
charging your facility for the cost of on-site monitoring
requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information
seeking civil money penalties up to $11,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards
seeking to suspend or revoke your facility's FDA certificate
seeking a court injunction against your facility
See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).
FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.
Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection of your facility and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA's requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html
If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Deborah M. McGee, M.S., Southwest Regional Compliance Officer, by telephoning (214) 253-4935.
Dennis E . Baker
Regional Food and Drug Director
Southwest Regional Office