• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Foreign Labs Inspection List

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

List of Foreign 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 Classification Codes:
  • 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 Foreign GLP Inspections Since FY ’90

- A -

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

 
Laboratory Date
Inspected
Class



AB Astra
Sodertalje, Sweden
04-06-98 VAI



Bayer Inst of Toxicology Germany 01-25-93  NAI



Biokit S.A.  
Barcelona, Spain
10-05-98 NAI



Central Inst Experimental Ani.
Kawasaki City, Japan
07-30-01  VAI



Centro de Investigacion y Desarrollo Applicado S.A.L. (CIDASAL)
Barcelona, Spain
06-26-03 VAI
     
Centro de Investigacion y Desarrollo Farmaceutico (CIDF)
Barcelona, Spain
06-23-03 VAI
     
Charles River Laboratories
Elphinstone Res Centre
Tranent, Scotland, UK
fka: Inveresk Res International
Midlothian, Scotland
09-04-95 NAI
  08-07-06 PEN
     
Charles River Laboratories
fka: ClinTrials BioResearch Ltd.
fka: Bioresearch Laboratories
Senneville, Quebec, Canada
04-29-91 VAI-2
  04-13-92  NAI
  04-07-97 VAI
  10-18-99 NAI
  05-01-00 OAI
     
Chinion Co. Ltd
Preclin Metab & Pharma
Budapest, Hungary
06-20-05 VAI
     
Chrysalis Preclin. Serv. Europe
fka: Pharmakon Europe
L’Arbresle, France
08-28-95 VAI
     
C.I.T. International Tox Cen
Miserey Evreux, France
07-22-93 VAI-2
     
Covance Labs Ltd.
fka: Corning Hazleton Europe
Harrogate, England
12-02-96 NAI
  04-14-98 VAI
     
Dainippon Pharm Co
Osaka, Japan
09-27-93 NAI



Dako A S  
Glostrup, Denmark
09-21-98 VAI
     

- E -

A-D   E-H   I-M    N-R   S-Z Glossary

     
Fujisawa Pharm.
Osaka, Japan
08-22-94  NAI



Glaxo SpA
Verona, Italy
07-16-93  VAI



Green Cross Corp.  
Osaka, Japan
09-13-93 VAI



Grunenthal GmbH   Aachen-Eilendorf, Germany 01-29-93 NAI



Hoechst-Marion Roussel
Milton Keyes, Bucks, England
07-27-98  NAI



Hoffmann-La Roche  
Basle, Switzerland
04-18-95 VAI



Huntingdon Life Sci Res Cen 
Huntingdon, England    
09-23-93 VAI-2

02-07-94 VAI

06-13-94 VAI

10-07-96 VAI



Huntingdon Life Sci
fka: Pharmaco::LSR
fka: Life Sci Res.
Essex, England
06-06-94 NCC

05-08-00 VAI



- I -

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




Institut fur Toxikologie und Chemo.
Deutches Krebforschungezentrum
Heidelberg, Germany
01-16-97  NAI



ITR Laboratories Canada
Quebec, Canada 
06-07-93 VAI-2

08-08-95 NAI



Janssen Pharm. 
Beerse, Belgium
09-13-93 VAI-3
     
Japan Seigiken Res  
Hamamatsu, Shizuoka, Japan
09-20-93 VAI



Korea Inst of Toxicology
Korea Res Inst of Chem Tech
Daejeon, Republic of Korea
12-05-05 PEN



Lab fur Pharm und Tox  
Hamburg, Germany
01-20-97 NAI



LAB Preclinical Res International
Laval, Quebec, Canada
04-05-04 NAI
     
Lab of Molecular Endocrin
(LREM)
Cen Hosp Univ Laval (CHUL)
Res Cen
Ste-Foy, Quebec, Canada
11-04-02 OAI



Montreal Heart Inst
Montreal, Quebec, Canada
06-02-03 NIM



- N -

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




Oxo Chemie GmbH  
Heidelberg, Germany
01-13-97 OAI



RBM Inst (A. Marxer) 
Ivrea, Italy 
07-12-93 VAI

08-21-95 NAI



Rhone Poulenc Rorer 
Vitry sur Seine, France
08-03-93 VAI-2



- S -

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




SmithKline Beecham Pharm
Harlow Essex, England
09-17-93 VAI-2



Sterling Winthrop
Northumberland, England
09-29-93  VAI



Sterling Research Group  
Longvic, France
07-28-93 VAI-2



Syngenta Central Toxicology Lab
fka: Central Toxicology Lab
Cheshire, England
05-02-00 VAI






Takeda Chem Industry  
Osaka, Japan
09-05-94 VAI



Thomae, Karl GmbH 
Biberach ander Riss, Germany
02-08-93 NAI



Wellcome Research Labs
Beckenham, England
09-24-93 VAI-2






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

-