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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aspen Medical Group 14-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis, MN 55401-1999

Telephone: 612-334-4100

January 14, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 20

Thomas Holets

Chief Executive Officer

Aspen Medical Group

102 1 Bandana Boulevard

St. Paul, Minnesota 55108

Dear Mr. Holets:

On December 20, 2001, a representative of the State of Minnesota, acting on behalf

of the Food and Drug Administration (FDA), inspected your Aspen Medical Group

facility located at 1850 Beam Avenue, Maplewood, Minnesota 55109, FDA Certificate #221235. 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. Based on the documentation your site

presented at the time of the inspection, the following non-compliances were

documented at your facility:

Repeat Level 2 Non-Compliance:

1. Corrective action before further exams, for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory limits, was not documented for the mammography unit [redacted] PROF; Mammography room, ACR unit designation = 1).

Additionally, please respond to the following non-compliance:

Repeat Level 3 Non-Compliance:

2. The freer retention QC is inadequate for the mammography film processor

([redacted] because the fixer retention QC tests were not done at the required frequency.

The specific problems noted above appeared on your MQSA Post Inspection Report

which was issued to your facility following the close of the inspection. Additional

Level 3 issues were also documented. A non-compliance is identified as a "repeat"

if it was cited during the previous inspection.

Because these conditions may be symptomatic of serious underlying problems that

could compromise the quality of mammography at your facility, they represent 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 penalties up to $10,000 for each

failure to substantially comply with, 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.

It is necessary for you to act on this matter immediately. Please explain to this

office in writing within 15 working days from the date you received this letter:

  • the specific steps you have taken to correct all of the 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.

Please submit your response to Thomas W. Garvin, Radiological Health Specialist,

Food and Drug Administration, 2675 No. Mayfair Road, Suite 200, Milwaukee, WI

53226- 1305.

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 (1-800-838-7715) or

through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have specific questions about mammography facility requirements or about

the content of this letter, please feel free to phone Mr. Garvin at (414) 771-7167

ext. 12.

Sincerely,

David R. Yost

Acting Director

Minneapolis District