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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Florida Medical Center Hospital 03-Jun-02

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


Food and Drug Administration
555 Winderley- Pl., Ste. 200
Maitland, FL 32751

VIA FEDERAL EXPRESS
WARNING LETTER
FLA-02-45
June 3, 2002

FACILITY ID # 161455

Michael Gittleman, CEO
Florida Medical Center Hospital
5000 W. Oakland Blvd
Ft. Lauderdale, Florida 33313

Dear Mr. Gittleman:

We are writing to you because on April 18, 2002, a representative of the State of Florida, acting on behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed serious regulatory problems involving the mammography at your facility.

Under United States Federal law, the Mammography Quality Standards Act 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. The inspection revealed the following violations at your facility:

  1. Your firm failed to conduct daily quality control tests as required by 21 CFR 900.12(e)(1) (i), (ii), (iii). For example, film processors used to develop mammograms shall be adjusted and maintained to meet the technical development specifications for the mammography film in use; processor performance tests shall be performed on each day that clinical films are processed before any clinical films are processed that day; and tests shall include an assessment of base plus fog density, mid-density, and density difference, using the mammography film used clinically at the facility. Processor QC records were missing on January 24, 25, 28, 29, and 30, 2002.

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at 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 $10,000.00 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 fifteen (15) working days from the date you receive 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 Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Ste. 200, Maitland, Florida 32751, telephone no. (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, Maryland 21045-6057, telephone no. (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 contact D. Janneth Caycedo, Consumer Safety Officer, Boca Resident Post, Food and Drug Administration, Interstate Plaza, 1499 W. Palmetto Park Rd., Ste. 110, Boca Raton, Florida 33486, telephone no. (561) 338-5236, ext. 23.

Sincerely,

/s/

Emma R. Singleton

Director, Florida District