List of
University Labs - GLP Inspections Since FY 90 |
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Last Update:
November 21, 2006 tf |
About the List:
Nonclinical laboratory studies are experiments in
which test articles (food additives, color additives,
drug or biological products, electronic products, medical
devices for human use) are studied in test systems (animals,
plants, microorganisms, or subparts thereof) under laboratory
conditions to determine their safety.
The Food and Drug Administration (FDA) regulates the
conduct of nonclinical laboratory studies under Part 58
(Good Laboratory Practice for Nonclinical Laboratory Studies)
of Title 21 of the Code of Federal Regulations. FDA inspects
facilities that conduct nonclinical laboratory studies
to determine the facilities compliance with part 58.
The following is a list of the testing facilities that
have been inspected since October 1, 1989. The list provides
the current name and former (if known) names of the testing
facility, the dates the facility has been inspected, and
the classification of the inspection results (see description
below). The list is updated quarterly.
The inspection dates may not be in chronological order
because the inspection assignments are issued on a quarterly
basis and reports may not have been entered in chronological
order. |
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Contact:
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Ruark Lanham
MSODL Investigator / Program Expert
Bioresearch Monitoring
Division of Field Investigations, HFC0-130
Office of Regulatory Affairs
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Phone: (301) 827 - 6691
Electronic mail: Ruark.Lanham@fda.hhs.gov
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Inspection ClassificationCodes
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CAN: Canceled
NAI: No Action Indicated. No objectionable
conditions or practices were found during the inspection
(or the objectionable conditions found do not justify
further regulatory action).
NCC: Non Classified
NIM: No Inspection Made.
OAI: Official Action Indicated. Regulatory
and administrative actions will be recommended.
PEN: Pending review and classification.
RTC: Refer to Center: Establishment
Inspection Report had been forwarded to Center for
final review and classification.
VAI: Voluntary Action Indicated. Objectionable
conditions or practices were found, but the agency
is not prepared to take or recommend any administrative
or regulatory action.
WO: Washout: Firm was visited or inspected,
however, not performing regulated studies at time
of inspection.
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Classification Codes No Longer in Use:
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VAI-1: Establishment has made voluntary corrections
in such a manner that the objectionable conditions
are not likely to recur and routine reinspection is
indicated.
VAI-2: Establishment advised by investigator
or other district communication of objectionable conditions
that should be corrected; however, the significance
is such that routine reinspection is indicated.
VAI-3: Objectionable conditions do not justify
official action at this time but the evidence shows
that the conditions, if not corrected, could reasonably
result in or lead to conditions that would support
official action.
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Miscellaneous
Abbreviations: |
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List of
University Labs - GLP Inspections Since FY 90 |
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Laboratory |
Date
Inspected |
Class |
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Auburn University
Auburn, AL |
06-26-95 |
NAI |
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Biomedical Engineering &
Experimental Cardiovascular Center
fka: Brigham and Women’s Hospital
Cardiovascular Div – ECI Lab
Harvard-MIT Biomed Eng Cen
Boston, MA |
01-13-04 |
OAI |
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03-21-06 |
PEN |
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Case Western Reserve
University
Cleveland, OH |
06-13-94 |
OAI |
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10-30-03 |
OAI |
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05-05-05 |
WO |
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Colorado State Univ. Res
Foundation
Maxwell Ranch
Livermore, CO |
01-16-92 |
VAI-2 |
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07-31-03 |
NAI |
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Colorado State Univ.
College of Vet Med & Biomed Sci
Vet Teaching Hosp
Ft. Collins, CO
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04-17-95 |
VAI |
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08-31-98 |
NAI |
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12-08-99 |
OAI |
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07-20-05 |
PEN |
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07-10-06 |
VAI |
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Colorado State Univ.
College of Vet Med
Animal Reproduction Lab
Ft. Collins, CO |
06-23-04 |
VAI |
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Columbia University
Dept of Medicine
New York, NY |
04-05-00 |
NAI |
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Cornell Univ.
Coll of Vet Med
Dr. B. Tennant
Ithaca, NY |
07-01-94 |
NAI |
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- E - |
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Harbor – UCLA Res & Educ Inst Med
Cen
Los Angeles Biomedical Res Inst
Torrence, CA |
01-20-05 |
VAI |
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Harvard Med. Sch.
Cardiac Surg Res Lab
Boston, MA |
03-05-97 |
NAI |
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Harvard Medical School
Laser Research Lab
Boston, MA |
02-06-00 |
VAI |
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- I - |
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Indiana Univ. Sch Dent
Oral Hlth Res Inst
Indianapolis, IN |
02-14-94 |
VAI |
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Iowa State Univ.
Ames, IA |
02-26-96 |
NAI |
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Johns Hopkins Sch of Med
Dept of Psyc & Behav.
Baltimore, MD |
02-08-93 |
NAI |
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Kansas State Univ.
Larry Corah
Weber Hall
Manhattan, KS |
03-15-93 |
VAI-3 |
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Kansas State Univ.
S.M. Kruckenberg
Manhattan, KS |
03-10-93 |
NAI |
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Kansas Univ Med Cen Res Inst
Kansas City, KS |
06-29-05 |
NAI |
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Louisiana State Univ.
Baton Rouge, LA |
09-14-93 |
VAI |
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Medical Coll of Georgia
Sch of Dentistry
Dept of Oral Biol
Augusta, GA |
03-09-93 |
NAI |
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Medical Coll of Virginia
Dept of Pharmacology
Richmond, VA |
11-17-93 |
NAI |
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Medical Coll of Virginia
Dept of Medicinal Chem
Richmond, VA |
01-11-93 |
NAI |
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Medical Coll of Wisconsin
Milwaukee, WI |
07-25-94 |
VAI |
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05-16-05 |
PEN |
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- N - |
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New Mexico State Univ
Dept of Animal & Range Sci
Las Cruces, NM |
02-02-05 |
PEN |
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North Caroliina State Univ
Lab Adv Lght & Elec Op Meth
Coll of Vet Med
Raleigh, NC |
03-22-04 |
VAI |
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NYU Medical Center
Dept of Pathology
Berg Inst Ani Facil.
New York, NY |
04-15-91 |
OAI |
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Ohio State University
Dept of Surgery
Columbus, OH |
05-11-98 |
OAI |
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Ohio State University
Veterinary Hospital
Columbus, OH |
11-14-01 |
NAI |
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Oklahoma State Univ.
Coll of Vet Med
Stillwater, OK |
07-09-91 |
NAI |
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08-04-03 |
PEN |
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Oregon Health Science Univ.
Kresege Hearing Res.
Portland, OR |
04-02-97 |
VAI |
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Penn State Univ.
Hershey Medical Center
Hershey, PA |
01-30-95 |
NAI |
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06-26-06 |
NAI |
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Rutgers University
Office of Res & Spon Prgms
New Brunswick, NJ |
07-08-05 |
NIM |
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- S - |
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Stanford University Med Cen
Sch. Of Medicine
Exp Coronary Interv Lab
Falk Cardiovascular Res
Stanford, CA |
06-26-00 |
VAI |
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05-09-06 |
PEN |
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State Univ of New York
(SUNY @ Buffalo)
Dept of Nuclear Med
Buffalo, NY |
08-10-92 |
OAI |
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State Univ of New York
(SUNY @ Buffalo)
Comp Med – Lab Ani Facility
Buffalo, NY |
02-22-05 |
OAI |
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Texas Southern Univ.
Dept of Biology
Houston, TX |
03-04-97 |
OAI |
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06-18-97 |
OAI |
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Texas Tech Univ.
Dept of Ani Science
Lubbock, TX |
01-17-96 |
VAI |
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Thomas Jefferson Univ.
Jefferson Med College
Philadelphia, PA |
09-15-98 |
WO |
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Tulane University
Dept of Endocrinology
New Orleans, LA |
06-20-94 |
OAI |
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Tulane Univ Hlth Sci Cen
Tulane School of Med
Dept Orthopedic Surgery
New Orleans, LA |
02-06-95 |
OAI |
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10-22-03 |
NAI |
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Univ. Of Arizona
Dept of Pharm Tox
Tucson, AZ |
02-01-93 |
NAI |
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Univ. Of Arizona
Health Science Center
Tucson, AZ |
09-18-00 |
OAI |
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11-20-02 |
NAI |
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05-15-06 |
NAI |
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Univ. Of California @ Davis
Fred H. Troutt
Tulare, CA |
05-03-93 |
VAI-3 |
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Univ. Of California @ Irvine
Dept of Ophthal & Derm
Irvine, CA |
07-08-91 |
OAI |
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Univ. Of California, L.A.
Dept of Surgery
Los Angeles, CA |
07-12-91 |
NAI |
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Univ. Of California S.F.
San Francisco, CA |
12-15-94 |
VAI |
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01-08-01 |
OAI |
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07-14-03 |
OAI |
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04-26-05 |
WO |
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Univ. of California San Diego
Dept of Anesthesiology
San Diego, CA |
11-13-03 |
VAI |
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09-25-06 |
PEN |
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Univ. Of Chicago Med
Ctr
Div of Biological Sci
Chicago, IL |
12-15-03 |
NAI |
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Univ. Of Florida
Coll of Vet Med
Gainesville, FL |
10-19-92 |
WO |
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Univ. Of Illinois
Toxicology Res Lab
Chicago, IL |
01-04-93 |
OAI |
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11-18-97 |
OAI |
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10-15-98 |
NAI |
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01-24-01 |
OAI |
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Univ. Of Illinois
Urbana, IL |
11-13-95 |
NAI |
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10-18-95 |
VAI |
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03-10-98 |
NAI |
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04-04-01 |
NAI |
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Univ. of Iowa
Bone Healing Lab
Iowa City, IA |
02-04-05 |
OAI |
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Univ. of Louisiana @ Lafayette
New Iberia Res Cen
New Iberia, LA |
05-05-03 |
NAI |
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12-05-05 |
PEN |
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Univ. Of Louisiana @ Lafayette
Madison Hall
Lafayette, LA |
10-12-04 |
NAI |
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Univ. of Louisville
Jewish Hospital
Cardiovascular Innov Inst
Louisville, KY |
08-21-06 |
PEN |
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Univ. of Medicine & Dentistry
of New Jersey
Robert Wood Johnson
Med Sch
Camden, NJ |
01-12-04 |
VAI |
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Univ. of Miami
Miller Sch of Medicine
Miami, FL |
08-14-06 |
PEN |
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Univ. Of Michigan Med Ctr
Kresge Hearing Res. Inst.
Dept of Otolaryngology
Ann Arbor, MI |
01-28-91 |
OAI |
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03-23-98 |
OAI |
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10-18-99 |
VAI |
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Univ. Of Michigan
Dept of Pharmacology
Ann Arbor, MI |
06-28-93 |
NAI |
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Univ. of Minnesota
Exp Surgical Serv
Dept of Surgery
Minneapolis, MN |
09-18-06 |
PEN |
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Univ. Of Minnesota
(Otterby, Donald)
St. Paul, MN |
12-10-90 |
NCC |
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12-27-04 |
NIM |
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Univ. Of Missouri
Dalton Cardiovascular Res Cen
Columbia, MO |
11-12-04 |
NIM |
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Univ of Oklahoma Hlth Sci Cen
Dean A. McGee Eye Institute
Oklahoma City, OK |
10-30-92 |
VAI |
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08-08-05 |
OAI |
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Univ. Of Pennsylvania
Inst. Human Gene Therapy
Philadelphia, PA |
02-14-00 |
OAI |
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Univ. Of Pennsylvania
Dept of Dermatology
Philadelphia, PA |
02-05-90 |
OAI |
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Univ. Of Pittsburgh
School of Medicine
Pittsburgh, PA
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09-28-05 |
VAI |
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Univ. Of South Florida
Tampa, FL |
05-13-99 |
OAI |
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07-31-00 |
VAI |
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07-18-06 |
NAI |
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Univ. Of Southern California
Alfred E. Mann Inst for Biomed
Los Angeles, CA |
01-18-05 |
VAI |
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Univ. Of Southern California
Doheny Eye Inst
Los Angeles, CA |
01-27-05 |
NAI |
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Univ. Of Southern California
Dept. Of Vivaria
Los Angeles, CA |
09-25-00 |
NAI |
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Univ. Of Texas
Dallas, TX |
07-27-94 |
VAI |
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Univ. of Texas
MD Anderson Cancer Cen
Houston, TX |
01-05-05 |
NAI |
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Univ. of Texas Medical Branch
Galveston, TX |
09-25-06 |
NAI |
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Univ. Of Wisconsin-Milwaukee
(Wehrenberg & Hutz)
Sch of Allied Hlth Profession
Milwaukee, WI |
07-30-97 |
VAI |
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Virginia-Maryland Reg College
Blacksburg, VA |
05-31-94 |
OAI |
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Wake Forest Univ.
Bowman-Gray Sch of Med
Winston-Salem, NC |
08-20-90 |
OAI |
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Washington Univ
Sch of Med
Dept of Pathology
St. Louis, MO |
06-16-92 |
NAI |
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Washington Univ
Div of Comp Med
Dalton Cardiovascular Res Cen
St. Louis, MO |
04-19-05 |
VAI |
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