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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Advanced Medical Imaging Center 28-Sep-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
New Orleans District Office
6600 Plaza Drive, Suite 400
New Orleans, LA 70127

VIA FEDERAL EXPRESS
FACILITY ID# 166991
September 28, 2001
Warning Letter No. 01-NSV-41

Shirley Haase, Administraton
Advanced Medical Imaging Center
525 South Lawrence Street
Montgomery, AL 36104

Dear Ms. Haase:

Your facility was inspected on September 21, 2001 by a representative of the State of Alabama on contract to the Food and Drug Administration (FDA). This inspection revealed that your facility failed to comply with the Quality Standards for Mammography (Standards) as specified in Title 21, Code of Federal Regulations (CFR), Part 900.12, as follows:

Level 1

The system to communicate results is not adequate for site Advanced Medical Imaging Center because:

- There is no system in place to provide timely lay summaries.

  • There is no system in place to communicate serious or presumptive cases as soon as possible.

Level 2

Failed to produce documents verifying that the radiologic technologist [redacted] met the alternative initial requirement of having training specific to mammography under the interim regulations.

These specific deficiencies appeared on the Post Inspection Report given to your facility along with instructions on how to respond to these findings. These deficiencies may be symptomatic of serious problems that could compromise the quality of mammography at your facility and potentially overexpose both patients and employees involved with mammography.

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 cause of these deficiencies identified above and to promptly initiate permanent corrective action.

If you fail to properly address 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 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.

Within 15 working days after receiving this letter, you should notify & FDA in writing of each step your facility is taking to prevent the recurrence of any similar violations.

If your facility is unable to complete these corrective actions within 15 working days, you should state the reason for the delay and the time within which the corrections will be completed.

Your reply should be directed to Joseph E. Hayes, Compliance Officer, Food and Drug Administration, 297 Plus Park Boulevard, Nashville, Tennessee 37217, telephone 615-781-5389, extension 125, with a copy to the State of Alabama Should you have questions regarding this letter or MQSA standards, you may call Karen Smallwood Radiation Specialist at 615-781-5380, extension 144.

Sincerely,
Carl E. Draper
Director, New Orleans District