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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Women's Health Center of Logansport 21-Mar-02

DEPARTMENT of Health and Human Services

Food and Drug Administration

Detroit District

1560 East Jefferson Avenue

Detroit, MI 46207-3179

Telephone: 313-226-6260

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

2002-DT-23

March 21, 2002

Ms. Joan A. Burton

Mammography Supervisor

Women? s Health Center of Logansport

1201 Michigan Avenue, Suite 170

Logansport, Indiana 46947

Dear Ms. Burton:

We are writing you because on March 6, 2002 your facility was inspected by representative of the State of Indiana acting in behalf of the Food & Drug

Administration (FDA). The 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 Repeat Level 2 finding at your facility:

There was no documentation of corrective action, prior to conducting further

mammography exams, when phantom image testing revealed a phantom

background of density difference outside of the allowable regulatory limit your [redacted]

mammography x-ray machine. This failure occurred on April 3, 10 and 24, 200l.

The specific problem noted above appeared on your MQSA Facility Inspection

Report (copy enclosed), which your facility received at the close of the inspection. This problem is identified as a Repeat Level 2 because it identifies a failure to meet a significant MQSA requirement and indicates failure by your facility to implement permanent correction of problem found during your previous inspection.

Because this condition may be symptomatic of serious underlying problems that

could compromise the quality of mammography at your facility, they represent a

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,

MQSA standards, suspension or revocation of your facility? s FDA certificate, or

obtaining a court injunction against performing further mammography.

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 receive this

letter:

  • the specific steps you have taken to correct the Repeat Level 2 violation noted in this letter;
  • each step your facility is taking to prevent the recurrence of similar violations;
  • 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 & Drug Administration

1560 East Jefferson Ave.

Detroit, MI 48207-3179

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, MD 21045-6057 (1-800-838-

7715) or through the Internet at www.fda.gov.

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,

David M. Kaszubski for Joann M. Givens

District Director

Detroit District Office