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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Burlington Imaging & Breast Center PA 07-Sep-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Atlanta District Office
60 Eighth Street, N.E.
Atlanta, Georgia 30309

September 7, 2001
VIA FEDERAL EXPRESS
Inspection ID: 2247830001
WARNING LETTER
(01-ATL-78)

John M. Nani
Mammography Administrator
Burlington Imaging & Breast Center PA
1225 Huffman Mill Road, Suite 101
Burlington, NC 27215

Dear Mr. Nani:

Your facility was inspected on 8/28/01 by a representative of the North Carolina Department of Environment & Natural Resources (DENR), Division of Radiation Protection, acting on behalf of the Food and Drug Administration (FDA) . This inspection revealed that your facility failed to comply with certain Quality Standards for Mammography as specified in Title 21, Code of Federal Regulations (CFR) , Part 900.12, as follows:

Mammograms were processed in processor #l, [redacted] when it was out of limits on at least 5 days.

The specific deficiency noted above appeared under the Level 1 heading on your MQSA Facility Inspection Report, which was issued at the close of the inspection. This deficiency may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility. In addition, your response should address the Level 2 noncompliance items that were listed on the inspection report. The Level 2 noncompliance items are:

Processor QC records in the month of 03/2001 were missing for at least 10% but less than 30% of operating days, for processor #1 described above.

Phantom QC records were missing for at least two weeks but less than four weeks for unit #1, [redacted] located in the Mammo room.

Failure to produce documents verifying that the medical physicist, [redacted] met the continuing education requirement t or completed at least 15 continuing education units in mammography in 36 months.

The other item listed in your facility inspection report, identified as Level 3 noncompliance, should also be corrected. We will verify correction of this item during our next inspection.

It is your responsibility to ensure adherence to each requirement of the Mammography Quality Standards Act of 1992 (MQSA) and FDA?s regulations. You are responsible for investigating and determining the causes of the deficiencies that the inspection identifies and promptly initiating permanent corrective actions.

If you fail to promptly correct these deficiencies, FDA may, without further notice, initiate regulatory action. Under MQSA, FDA may:

  • impose civil money penalties on a facility of up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, the Standards.
  • suspend or revoke a facility?s FDA certificate for failure to comply with the Standards.
  • seek an injunction in federal court to prohibit any mammography activity that constitutes a serious risk to human health.

Please note that FDA regulations do not preclude a State from enforcing its own State mammography laws and regulations. In some cases, these requirements may be more stringent than FDA?s. When you plan your corrective action(s), therefore, you should consider the more stringent State requirements, if any. Within 15 working days after receiving this letter, you should notify FDA in writing of :

the specific steps you have taken to correct all of the violations noted in this letter;

each step your facility is taking to prevent the recurrence of similar violations;

equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and

sample records that demonstrate proper recordkeeping procedures, if the noncompliances that were found relate to quality control or other records. (Note: Patient names or

identification should be deleted from any copies submitted.)

If your facility is unable to complete the corrective action within 15 working days, you should state the reason for the delay and the time within which corrections will be completed. Please send the original copy of your response to:

Serene A. Kimel, Compliance Officer
U.S. Food and Drug Administration
60 8th St., NE
Atlanta, GA 30309

With a copy to:

North Carolina DENR
Division of Radiation Protection
3825 Barrett Drive
Raleigh, NC 27609-7221

and

Thomas Clarida
US Food and Drug Administration
5701 Executive Center Drive, Suite104
Charlotte, NC 28212

Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection 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.

You may choose to address both FDA and state requirements in your response. If you have any questions regarding this letter or how to ensure you are meeting MQSA standards, please call Thomas Clarida at 704-344-6116.

Sincerely yours,
Ballard H. Graham
Atlanta District
Director