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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Imaging Associates, Inc. 17-Aug-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

August 17, 2001
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Reference: Warning Letter SEA 01-77
Inspection ID: 2072250006
WARNING LETTER

Sharon Haworth, Chief Technologist
Imaging Associates, Inc.
901 Boren, Suite 1920
Seattle, WA 98104

Dear Ms. Haworth:

We are writing to you because on August 6,2001, a representative of the State of Washington, Mr. Bill Van Pelt, acting on behalf of the Food and Drug Administration (FDA), inspected Mobile Unit 3 operated by your facility. 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, 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:

1. Corrective action before further exams for a failing phantom image outside the allowable regulatory limits was not documented for unit 1,[redacted] Mobile Unit 3.

The specific problems noted above appeared on your MQSA Facility Inspection Report which was issued to your facility 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.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents 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 H)A 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 fifteen (15) working days horn 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 (Note: patient names or identification should be deleted from any copies submitted). *

Please submit your response to U.S. Food & Drug Administration, Attention: Thomas S. Piekarski, Compliance Officer, 22201 23rd Drive, SE, Bothell, Washington 98021-4421.

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, Maryland 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov.

*This note is not applicable for letters that also address patient notification.

Sincerely,

Charles M. Breen

District Director