Inspections, Compliance, Enforcement, and Criminal Investigations
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
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
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
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.
Emma R. Singleton
Director, Florida District