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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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F.E. Warren AFB 21-Jun-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

  Food and Drug Administration
SOUTHWEST REGION
Office of the Regional
Food and Drug Director
7920 Elmbrook Drive, Suite 102
Dallas, TX 75247-4982
TELEPHONE: 214-655-8100
FACSIMILE: 214-655-8130


 

 

 

June 21, 2001


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Charles Ariz, M.D.
Lead Interpreting Physician
90 MDGSGSAR
F.E. Warren AFB
6900 Alden Drive
F.E. Warren AFB, WY 82005-3913


01-SWR-WL-5618

RE: Inspection ID -1449490006

Dear Charles Ariz,

On June 15,2001, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious regulatory problem involving the mammography at your facility.

The Mammography Quality Standards Act of 1992 requires your facility to meet specific standards. These requirements help protect the health of women by assuring that a facility can perform quality marnmography. The inspection revealed the following repeated level 2 finding at your facility:

Level 2 repeat: The measured fog density is equal to 0.1 for darkroom.

[A finding is considered a repeat finding if the same type of violation was cited during the previous inspection, whether or not the finding is associated with the same piece of equipment (x-ray unit, processor, or darkroom) or the same personnel in a given category.]

The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection.

Level 1 and repeated level 2 findings maybe symptomatic of serious underlying problems that could compromise the quality of mammography at your facility. They represent a serious violation of the law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to:

  • Placing your facility under a Directed Plan of Correction.
  • Charging your facility for the cost of on-site monitoring.
  • Assessing civil money penalties up to $10,000 for each failure to substantially comply with, or
    each day of failure to substantially comply with, the Standards.
  • Suspension or revocation of your facility’s FDA certificate, or obtaining a court injunction
    against further mammography.

In addition, your response should address the level 2 findings that were listed on the inspection report provided to you at the close of the inspection. The inspection revealed the following level 2 findings:

Level 2: Phantom QC records missing for at least two weeks but less than four weeks for unit 2, Bennett X-Ray Corp., CON+.

Level 2: Medical audit and outcome analysis was not performed annually.

It is necessary for you to act on this matter immediately. You are required to respond to this office in writing within fifteen (15) working days from receipt of this letter. Please address the following:

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.

Sample records that demonstrate proper record keeping procedures, if the findings relate to quality control or other records (Note: Patient names or identification should be deleted from any copies submitted).

Please submit your response to:

Deborah M. McGee, Radiation Specialist
Food and Drug Administration
7920 Elmbrook Drive, Suite 102
Dallas, TX 75247-4982

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 (1-800-838-771 5) or through the Internet at http://www.fda. gov.