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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Nova Southeastern University 12-Mar-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

555 Winderley Pl., Ste. 200

Maitland, FL 32751

VIA FEDERAL EXPRESS

WARNING LETTER

FLA-02-33

March 12, 2002

FACILITY ID #181246

Terry Morton, Chancellor Health Professions

Nova Southeastern University

3200 South University Drive

Davie, Florida 33328

Dear Mr. Morton:

We are writing to you because on February 6, 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

USC 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.

Pursuant to 21 CFR 900.12(e)(2), your facility did not have Phantom QC records for a

minimum of four weeks for Unit 2, Elscint, Inc., Mammo room. The dates of missing

records are as follows (2001): 3/l 0, 3/l 7, 3/24, 4/l 2, 4/l 9, 4/26, 5/l 1, 5/l 8, 5/25, 6/12,

6/l 9, 6/26, 7/12, 7/l 9, 7126, 8/l 3, 8120, 8127, 9/l 2, 9/l 9, 9/26, 10/l 2, 10/l 9, 10/26,

11/12, 11/19, 11/26, 12/12, 12/19, and 12/26.

Pursuant to 21 CFR 900.12(a)(l)(D)(ii)(A), your facility failed to produce documents

verifying that the interpreting physician, [redacted] experience requirement of having interpreted or multi-read met the continuing 960 mammograms in the 24 months immediately preceding the date of the facility? s annual MQSA inspection or the

last day of the calendar quarter preceding the inspection or any date in-between the

two.

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 $10,000.00r 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. (l-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, 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,

Emma R. Singleton

Director, Florida District