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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Ballas Imaging Center 19-Apr-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration
Southwest Region
7920 Elmbrook Drive
Suite 102
Dallas, TX 75247-4982
Telephone: 214-855-8100
FAX: 214-655-8130

April 19, 2002
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
02-SWR-WL-37/0
Re: Inspection ID ? 1717690007

Anthony A. Bemi, M. D.
President
Ballas Imaging Center
777 S. New Ballas Road, Suite 121E
St. Louis, MO 63141

Dear Mr. Bemi:

We are writing to you because on March 14, 2002, a representative of the State of Missouri, acting on behalf of the Food and Drug Administration (FDA), inspected your facility. This inspection revealed a serious regulatory problem involving the mammography at your facility. Under a United States Federal law, the Mammography Quality Standards Act of 1992 (MQSA), your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following violation of Section 354(f) of the Act at your facility:

Level 2 repeat: Phantom QC records were missing for at least two weeks but less than four weeks for unit 1, General Electric Co. (GE Medical Systems), 600. (see 21 CFR 900.12(e)(2)).

[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. A Level 1 or repeated Level 2 finding indicates that the inspector found one or more deviations from MQSA standards that may seriously compromise the quality of mammography services offered by the facility.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents 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 penalites up to $10,000 for each failure to substantially comply with, April 19, 2002 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 (see Sections 354(h) through (j) of the Act).

In addition, the inspection report provided to you at the close of the inspection listed a Level 2 violation. A Level 2 finding indicates that the facility? s performance is generally acceptable. However, the inspector did find one or more deviations from MQSA standards that may compromise the quality of mammography services offered by the facility. The inspection revealed the following level 2 finding:

Level 2: Medical audit and outcome analysis was not done separately for each individual. (see 21 CFR 900.12(f)(1)).

It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date you received this letter:

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

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

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

4. 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

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 (l-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Deborah M. McGee at (214) 6558100 extension 138.

Sincerely yours,

C.D. Evans for Gary Pirece

Regional Food and Drug Director