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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Duluth Clinic, Ltd. 03-Jun-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
Minneapolis District
240 Hennepin Avenue
Minneapolis, MN 55401-1999
Telephone: 612-334-4100

June 3, 2002
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 02 - 33

Peter Person, M.D.
Chief Executive Officer
The Duluth Clinic, Ltd.
400 East Third Street
Duluth, Minnesota 55805

Dear Dr. Person:

On April 16, 2002, a representative of the State of Minnesota, acting on behalf of the Food and Drug Administration (FDA), inspected your mammography facility (FDA Certificate # 142232). This inspection revealed a serious regulatory problem involving the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act (MQSA) of 1992, 42 U.S.C. 263b, 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. Phantom QC records were missing for at least two weeks but less than four weeks for mammography systems:

[redacted] OTH, Room 1 (ACR designation =Unit 6)

[redacted] OTH, Room 2 (ACR designation =Unit 5)

[redacted] OTH, Room 3 (ACR designation =Unit 4)

Evaluation criteria: Number of weeks missing in worst 12-week period.

The Image Quality Evaluation (phantom) test is required by Title 21 , Code of Federal Regulations, Part 900.12(e)(2) to be performed at least weekly.

Repeat Level 3 Non-Compliance

2. The screen-film contact QC is not adequate for The Duluth Clinic, Ltd. Site because the QC tests were not done at the required frequency [21 C.F.R. 900.12(e)(4)(ii)]

A non-compliance is annotated as "Repeat" if it was also cited during the prior inspection.

The specific problems noted above appeared on your MQSA Post Inspection Report which was issued to your facility following the close of the 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 you have taken 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 certain 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,

/s/

Cheryl A. Bigham
Acting Director
Minneapolis District