Inspections, Compliance, Enforcement, and Criminal Investigations
Women's Health Center of Logansport 21-Mar-02
DEPARTMENT of Health and Human Services
Food and Drug Administration
1560 East Jefferson Avenue
Detroit, MI 46207-3179
RETURN RECEIPT REQUESTED
March 21, 2002
Ms. Joan A. Burton
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
- 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.
David M. Kaszubski for Joann M. Givens
Detroit District Office