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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Advance Radiological Center 21-Aug-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
Detroit District
1560 East Jefferson Avenue
Detroit, Ml 48207-3179
Telephone. 313-226-6260

CERTIFIED MAIL
RETURN RECEIPT REOUESTED
WARNING LETTER
2001-DT-27
August 21, 2001

Melvin C, Murphy, M.D.
Advance Radiological Center
23077 Greenfield Rd., Suite 487
Southfield, MI 48075

Dear Dr. Murphy:

We are writing you because on August 9, 2001, your facility was inspected by a representative of the State of Michigan acting in behalf of the Food & Drug Administration (FDA). The inspection revealed 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 Level 1 and Repeat Level 2 findings at your facility:

  1. Mammograms were processed in your [redacted] film processor when it was out of limits on at least five (5) days.
  2. Corrective actions for processor QC failures were not documented at least once for the [redacted] processor.

The specific problems noted above appeared on your MQSA Facility Inspection Report (copy enclosed), which your facility personnel received at the close of the inspection. These problems are identified as Level 1 and Repeat Level 2 because they identify a failure to meet significant MQSA requirements.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents a violation of 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 MQSA 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 are also listed on the inspection report provided to your facility personnel at the close of the inspection. These Level 2 findings are:

1. Your facility has not specified adequate procedures to be followed for infection control in the event that equipment comes into contact with blood or other bodily fluids or potentially infectious materials. (Please see enclosed policy on infection control).

2. Corrective actions for a failing phantom image score. or a phantom background optical density or density difference outside the allowable regulatory limits, was not documented.

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:

  • the specific steps you have taken to correct the Level 1 and 2 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 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:

Mr. David M. Kaszubski
Director Compliance Branch
U.S. Food and Drug Administration
1560 East Jefferson Ave.
Detroit, MI 48207

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 actions, you should consider the more stringent State requirements, if any. You should also send a copy to the State of Indiana radiation control office that conducted the inspection referenced in this letter. You may choose to address both the FDA and any additional State requirements in your response.

Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter only pertains to findings of your inspection and does not necessarily address other obligations you have under 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, MD21045-6057 (1-800-838-7715) or through the Internet at http: /www.fda.gov/cdrh/mammogaphy.

If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Mr. Dennis E. Swartz, Radiological Health Expert, at 313-226-6260 Ext.155.

Sincerely yours,

/s/

District Director

Detroit District