Inspections, Compliance, Enforcement, and Criminal Investigations
Marlette Community Hospital 22-Feb-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
1560 East Jefferson Avenue
Detroit, MI 48207-3179
RETURN RECEIPT REQUESTED
February 22, 2002
Lionel Gorbaty, M.D.
Marlette Community Hospital
2770 Main Street
Marlette, MI 48453
Dear Dr. Gorbaty:
We are writing you because on February 20, 2002, your facility was inspected
by a representative of the State of Michigan 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:
Your mammography technologist, [redacted] did not have sufficient continuing
education credits to meet the requirement of 15 CEU?s within the previous 36
month period. Documentation available at the time of the inspection totaled 9.5
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 by your facility to implement permanent correction of the same 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, 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 onsite
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
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;
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 Michigan 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 http://www.fda.gov/cdrh/mammography.
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.