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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mammography & Ultrasound Specialists 31-Jan-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Southwest Regional Office
4040 North Central Expressway
Suite 900
Dallas, Texas 75204


WARNING LETTER

January 31, 2006

Via Federal Express - Next Day

Re: MQSA Inspection ID #204065 2006-SWR-01
FEI #1000517268

Gail Burleson
Chief Executive Officer
Mammography & Ultrasound Specialists
6611 S. Rice Avenue
Bellaire, TX 77401

Dear Ms. Burleson,

On January 10, 2006, a representative of the Food and Drug Administration (FDA) conducted an investigation 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 problem identified during this investigation constitutes a violation of the MQSA as identified below.

Failed to produce documents verifying that your facility was operating with a valid FDA MQSA certificate. Your current FDA MQSA certificate expired on October 31, 2005. Your facility has operated without a valid FDA MQSA certificate from November 1, 2005 through December 20, 2005. [See 21 CFR 900.11(a)].

Because this violation 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).

You should respond in writing to FDA within fifteen (15) working days from the date you receive this letter. Your response should address the findings listed above and include:

1. The specific steps you have taken, or will take to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;

2. The specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps.

Please submit your response to this letter to:

Deborah M. McGee
Food and Drug Administration
4040 N. Central Expressway, Suite 900
Dallas, TX 75204

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent investigation 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.

Sincerely yours,

/S/

Dennis E. Baker
Regional Food and Drug Director
Southwest Regional Office

cc:
Texas Department of State Health Services
Regulatory Services, Environmental and
Consumer, Inspection Unit
1100 W. 49th Street
Austin, TX 78756-3189
Attn: Jerry Cogburn

Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs,
American College of Radiology
1891 Preston White Drive
Reston, Virginia 22091