Inspections, Compliance, Enforcement, and Criminal Investigations
Putnam Diagnostic Imaging Center 27-Mar-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
555 Winderley PI., Ste. 200
Maitland, FL 32751
VIA FEDERAL EXPRESS
March 27, 2002
FACILITY ID # 218644
David Taylor, Administrator
Putnam Diagnostic Imaging Center
6905 Old Wolf Bay Road
Palatka, Florida 32177
Dear Mr. Taylor:
We are writing to you because, on February 15, 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 a 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 February 15,
2002 inspection revealed the following violations at your facility:
1. Failure to adjust and maintain film processors used to develop mammograms
to meet the technical development specifications for the mammography film in
use. A processor performance test is required to be performed on each day
that clinical films are processed before any clinical films are processed that
day. The test shall include an assessment of base plus fog density, mid-
density, and density difference as required by 21 CFR 900.12(e)(l)(i), (ii), (iii).
For example, mammograms were processed when the X-OMAT Kodak
processor (Mammo Room) was out of limits on twenty- three days.
Specifically, the speed and contrast indices were out of limits from April 26
through May 30, 2001 and new AIMS were repeatedly established without
documenting that the facility physicist was consulted.
2. Failure to identify and correct the source of problems discovered during the
comparison of the test results, for the tests specified in 21 CFR 900.12(e)(l)
through (7) to the corresponding specified action limits, or to the
manufacturer?s recommended action, before further exams or within thirty
days, as required by 21 CFR 900.12 (e)(8)(i) and ii(A). For example,
corrective actions were not documented for: (1) processor QC failures at least
once for processor 01, Kodak, RP X-OMAT M6B, 6AN, Mammo room; and (2)
for a failing image score, a phantom background optical density, or a density
difference outside the allowable regulatory limits before further exams were
performed for unit 1, Bennett X-Ray Corp., CONT., Mammo room. More
specifically, phantom QC contrast index was out of limits on March 1, 8, 10,
13, and 17, 2001. Phantom QC specks score failed on July 20, and 27, 2001.
Mammograms were performed on these days and no corrective actions were
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 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
- 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, 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/cdrh/mammography.
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.
Emma R. Singleton
Director, Florida District