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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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University Labs Inspection List

Nonclinical Laboratories Inspected
Under FDA GLP Regulations
(Title 21, Code of Federal Regulations, Part 58)
SINCE FISCAL YEAR 1990

List of University Labs - GLP Inspections Since FY ’90

Contents

 

Introduction - Contents - Glossary

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.

 
 Contact:
  • 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
 

Glossary

 Inspection ClassificationCodes
  • 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.

 Classification Codes No Longer in Use:
  • 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.

 Miscellaneous Abbreviations:
  • dba: Doing Business As.

    fka: Formerly Known As - Former name(s) of the establishment.

    OOB: Establishment is Out of Business as a nonclinical laboratory.

 

List of University Labs - GLP Inspections Since FY ’90

- A -

A-D   E-H    I-M   N-R   S-Z  Glossary

 
Laboratory Date
Inspected
Class
     
Auburn University
Auburn, AL
06-26-95 NAI
     
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
  03-21-06 PEN
     
Case Western Reserve
University
Cleveland, OH
06-13-94 OAI
  10-30-03 OAI
  05-05-05 WO
     
Colorado State Univ. Res
Foundation
Maxwell Ranch
Livermore, CO
01-16-92 VAI-2
  07-31-03 NAI
     
Colorado State Univ.
College of Vet Med & Biomed Sci
Vet Teaching Hosp
Ft. Collins, CO
04-17-95 VAI
  08-31-98 NAI
  12-08-99 OAI
  07-20-05 PEN
  07-10-06 VAI
     
Colorado State Univ.
College of Vet Med
Animal Reproduction Lab
Ft. Collins, CO
06-23-04 VAI
     
Columbia University
Dept of Medicine
New York, NY
04-05-00 NAI
     
Cornell Univ.
Coll of Vet Med
Dr. B. Tennant
Ithaca, NY
07-01-94 NAI
     

- E -

A-D   E-H   I-M    N-R   S-Z Glossary

     
Harbor – UCLA Res & Educ Inst Med Cen
Los Angeles Biomedical Res Inst
Torrence, CA
01-20-05 VAI
     
Harvard Med. Sch.
Cardiac Surg Res Lab
Boston, MA
03-05-97 NAI
     
Harvard Medical School
Laser Research Lab
Boston, MA
02-06-00 VAI
     

- I -

A-D   E-H    I-M   N-R   S-Z  Glossary

     
Indiana Univ. Sch Dent
Oral Hlth Res Inst
Indianapolis, IN
02-14-94 VAI
     
Iowa State Univ.
Ames, IA
02-26-96 NAI
     
Johns Hopkins Sch of Med
Dept of Psyc & Behav.
Baltimore, MD
02-08-93 NAI
     
Kansas State Univ. 
Larry Corah
Weber Hall
Manhattan, KS
03-15-93 VAI-3
     
Kansas State Univ.  
S.M. Kruckenberg
Manhattan, KS
03-10-93 NAI
     
Kansas Univ Med Cen Res Inst
Kansas City, KS
06-29-05 NAI
     
Louisiana State Univ.
Baton Rouge, LA
09-14-93 VAI
     
Medical Coll of Georgia
Sch of Dentistry
Dept of Oral Biol
Augusta, GA
03-09-93 NAI
     
Medical Coll of Virginia
Dept of Pharmacology
Richmond, VA
11-17-93 NAI
     
Medical Coll of Virginia
Dept of Medicinal Chem
Richmond, VA
01-11-93 NAI
     
Medical Coll of Wisconsin
Milwaukee, WI
07-25-94 VAI
  05-16-05 PEN
     

- N -

A-D   E-H    I-M   N-R   S-Z  Glossary

     
New Mexico State Univ
Dept of Animal & Range Sci
Las Cruces, NM
02-02-05 PEN
     
North Caroliina State Univ
Lab Adv Lght & Elec Op Meth
Coll of Vet Med
Raleigh, NC
03-22-04 VAI
     
NYU Medical Center
Dept of Pathology
Berg Inst Ani Facil.
New York, NY
04-15-91 OAI
     
Ohio State University
Dept of Surgery
Columbus, OH
05-11-98 OAI
     
Ohio State University
Veterinary Hospital
Columbus, OH
11-14-01 NAI
     
Oklahoma State Univ.
Coll of Vet Med
Stillwater, OK
07-09-91 NAI
  08-04-03 PEN
     
Oregon Health Science Univ.
Kresege Hearing Res.
Portland, OR
04-02-97 VAI
     
Penn State Univ.
Hershey Medical Center
Hershey, PA
01-30-95 NAI
  06-26-06 NAI
     
Rutgers University
Office of Res & Spon Prgms
New Brunswick, NJ
07-08-05 NIM
     

- S -

A-D   E-H    I-M   N-R   S-Z  Glossary

     
Stanford University Med Cen
Sch. Of Medicine
Exp Coronary Interv Lab
Falk Cardiovascular Res
Stanford, CA
06-26-00 VAI
  05-09-06 PEN
     
State Univ of New York
(SUNY @ Buffalo)
Dept of Nuclear Med
Buffalo, NY
08-10-92 OAI
     
State Univ of New York
(SUNY @ Buffalo)
Comp Med – Lab Ani Facility
Buffalo, NY
02-22-05 OAI
     
Texas Southern Univ.
Dept of Biology
Houston, TX
03-04-97 OAI
  06-18-97 OAI
     
Texas Tech Univ.
Dept of Ani Science
Lubbock, TX
01-17-96 VAI
     
Thomas Jefferson Univ.
Jefferson Med College
Philadelphia, PA
09-15-98 WO
     
Tulane University
Dept of Endocrinology
New Orleans, LA
06-20-94 OAI
     
Tulane Univ Hlth Sci Cen
Tulane School of Med
Dept Orthopedic Surgery
New Orleans, LA
02-06-95 OAI
  10-22-03 NAI
     
Univ. Of Arizona
Dept of Pharm Tox
Tucson, AZ
02-01-93 NAI
     
Univ. Of Arizona
Health Science Center
Tucson, AZ
09-18-00 OAI
  11-20-02 NAI
  05-15-06 NAI
     
Univ. Of California @ Davis
Fred H. Troutt
Tulare, CA
05-03-93 VAI-3
     
Univ. Of California @ Irvine
Dept of Ophthal & Derm
Irvine, CA
07-08-91 OAI
     
Univ. Of California, L.A.
Dept of Surgery
Los Angeles, CA
07-12-91 NAI
     
Univ. Of California S.F.
San Francisco, CA
12-15-94 VAI
  01-08-01 OAI
  07-14-03 OAI
  04-26-05 WO
     
Univ. of California San Diego
Dept of Anesthesiology
San Diego, CA
11-13-03 VAI
  09-25-06 PEN
     
Univ. Of Chicago Med
Ctr
Div of Biological Sci
Chicago, IL
12-15-03 NAI
     
Univ. Of Florida
Coll of Vet Med
Gainesville, FL
10-19-92 WO
     
Univ. Of Illinois
Toxicology Res Lab
Chicago, IL
01-04-93 OAI
  11-18-97 OAI
  10-15-98 NAI
  01-24-01 OAI
     
Univ. Of Illinois
Urbana, IL
11-13-95 NAI
  10-18-95 VAI
  03-10-98 NAI
  04-04-01 NAI
     
Univ. of Iowa
Bone Healing Lab
Iowa City, IA
02-04-05 OAI
     
Univ. of Louisiana @ Lafayette
New Iberia Res Cen
New Iberia, LA
05-05-03 NAI
  12-05-05 PEN
     
Univ. Of Louisiana @ Lafayette
Madison Hall
Lafayette, LA
10-12-04 NAI
     
Univ. of Louisville
Jewish Hospital
Cardiovascular Innov Inst
Louisville, KY
08-21-06 PEN
     
Univ. of Medicine & Dentistry of New Jersey
Robert Wood Johnson
Med Sch
Camden, NJ
01-12-04 VAI
     
Univ. of Miami
Miller Sch of Medicine
Miami, FL
08-14-06 PEN
     
Univ. Of Michigan Med Ctr
Kresge Hearing Res. Inst.
Dept of Otolaryngology
Ann Arbor, MI
01-28-91 OAI
  03-23-98 OAI
  10-18-99 VAI
     
Univ. Of Michigan
Dept of Pharmacology
Ann Arbor, MI
06-28-93 NAI
     
Univ. of Minnesota
Exp Surgical Serv
Dept of Surgery
Minneapolis, MN
09-18-06 PEN
     
Univ. Of Minnesota
(Otterby, Donald)
St. Paul, MN
12-10-90 NCC
  12-27-04 NIM
     
Univ. Of Missouri
Dalton Cardiovascular Res Cen
Columbia, MO
11-12-04 NIM
     
Univ of Oklahoma Hlth Sci Cen
Dean A. McGee Eye Institute
Oklahoma City, OK
10-30-92
VAI
  08-08-05 OAI
     
Univ. Of Pennsylvania
Inst. Human Gene Therapy
Philadelphia, PA
02-14-00 OAI
     
Univ. Of Pennsylvania
Dept of Dermatology
Philadelphia, PA
02-05-90 OAI
     
Univ. Of Pittsburgh
School of Medicine
Pittsburgh, PA
09-28-05 VAI
     
Univ. Of South Florida
Tampa, FL
05-13-99 OAI
  07-31-00 VAI
  07-18-06 NAI
     
Univ. Of Southern California
Alfred E. Mann Inst for Biomed
Los Angeles, CA
01-18-05 VAI
     
Univ. Of Southern California
Doheny Eye Inst
Los Angeles, CA
01-27-05 NAI
     
Univ. Of Southern California
Dept. Of Vivaria
Los Angeles, CA
09-25-00 NAI
     
Univ. Of Texas
Dallas, TX
07-27-94 VAI
     
Univ. of Texas
MD Anderson Cancer Cen
Houston, TX
01-05-05 NAI
     
Univ. of Texas Medical Branch
Galveston, TX
09-25-06 NAI
     
Univ. Of Wisconsin-Milwaukee
(Wehrenberg & Hutz)
Sch of Allied Hlth Profession
Milwaukee, WI
07-30-97 VAI
     
Virginia-Maryland Reg College
Blacksburg, VA
05-31-94 OAI
     
Wake Forest Univ.
Bowman-Gray Sch of Med
Winston-Salem, NC
08-20-90 OAI
     
Washington Univ
Sch of Med
Dept of Pathology
St. Louis, MO
06-16-92 NAI
     
Washington Univ
Div of Comp Med
Dalton Cardiovascular Res Cen
St. Louis, MO
04-19-05 VAI
     

A-D   E-H   I-M   N-R   S-Z  Glossary  Top of Page

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