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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Magnet of Palm Beach, LTD 09-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICE

Public Health Service

Food and Drug Administration

555 Winderley Pl., Ste. 200

Maitland, FL 32751

VIA FEDERAL EXPRESS

WARNING LETTER

FL-02-22

January 9, 2002

FACILITY ID # 142521

Connie McCoy, Center Manager

The Magnet of Palm Beach, LTD

4477 Medical Center Way

West Palm Beach, Florida 33409

Dear Ms. McCoy:

We are writing to you because on December 4,2001 a representative of the State of FL, acting in behalf of the Food and Drug Administration (FDA inspected 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 level I violation at your facility.

Level 1. Phantom QC records were missing for at least four weeks for two

General Electric x-ray units located in the DMR and Room 800.

The specific problem noted above appeared on your MQSA Facility inspection

Report, which was issued to your facility at the close of the inspection. 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 co ply 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 fifteen (15) working days from the date you received letter:

  • the specific steps you have taken to correct all of the violations noted 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,
  • samples of 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 Timothy J. Couzins, Compliance Officer, U.S.

Food & Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida

32751, (407) 475-4728.

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.

If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact D. Janneth Caycedo at 561-338-5236 ext. 23.

Sincerely yours,

Donna Langne for Emma R. Singleton

Director, Florida District