List
of Foreign 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
Classification Codes:
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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: -
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 Foreign GLP Inspections Since FY 90 |
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A - |
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Laboratory |
Date
Inspected |
Class |
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AB Astra
Sodertalje, Sweden |
04-06-98 |
VAI |
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Bayer Inst of Toxicology Germany |
01-25-93 |
NAI |
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Biokit S.A.
Barcelona, Spain |
10-05-98 |
NAI |
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Central Inst Experimental Ani.
Kawasaki City, Japan |
07-30-01 |
VAI |
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Centro de Investigacion y Desarrollo
Applicado S.A.L. (CIDASAL)
Barcelona, Spain |
06-26-03 |
VAI |
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Centro de Investigacion y Desarrollo
Farmaceutico (CIDF)
Barcelona, Spain |
06-23-03 |
VAI |
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Charles River Laboratories
Elphinstone Res Centre
Tranent, Scotland, UK
fka: Inveresk Res International
Midlothian, Scotland |
09-04-95 |
NAI |
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08-07-06 |
PEN |
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Charles River Laboratories fka: ClinTrials
BioResearch Ltd.
fka: Bioresearch Laboratories
Senneville, Quebec, Canada |
04-29-91 |
VAI-2 |
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04-13-92 |
NAI |
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04-07-97 |
VAI |
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10-18-99 |
NAI |
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05-01-00 |
OAI |
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Chinion Co. Ltd
Preclin Metab & Pharma
Budapest, Hungary |
06-20-05 |
VAI |
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Chrysalis Preclin. Serv. Europe
fka: Pharmakon Europe
LArbresle, France |
08-28-95 |
VAI |
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C.I.T. International Tox Cen
Miserey Evreux, France |
07-22-93 |
VAI-2 |
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Covance Labs Ltd.
fka: Corning Hazleton Europe
Harrogate, England |
12-02-96 |
NAI |
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04-14-98 |
VAI |
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Dainippon Pharm Co
Osaka, Japan |
09-27-93 |
NAI |
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Dako A S
Glostrup, Denmark |
09-21-98 |
VAI |
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- E - |
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Fujisawa Pharm.
Osaka, Japan |
08-22-94 |
NAI |
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Glaxo SpA
Verona, Italy |
07-16-93 |
VAI |
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Green Cross Corp.
Osaka, Japan |
09-13-93 |
VAI |
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Grunenthal GmbH Aachen-Eilendorf,
Germany |
01-29-93 |
NAI |
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Hoechst-Marion Roussel
Milton Keyes, Bucks, England |
07-27-98 |
NAI |
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Hoffmann-La Roche
Basle, Switzerland |
04-18-95 |
VAI |
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Huntingdon Life Sci Res Cen
Huntingdon, England |
09-23-93 |
VAI-2 |
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02-07-94 |
VAI |
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06-13-94 |
VAI |
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10-07-96 |
VAI |
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Huntingdon Life Sci
fka: Pharmaco::LSR
fka: Life Sci Res.
Essex, England |
06-06-94 |
NCC |
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05-08-00 |
VAI |
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I - |
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Institut fur Toxikologie und Chemo.
Deutches Krebforschungezentrum
Heidelberg, Germany |
01-16-97 |
NAI |
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ITR Laboratories Canada
Quebec, Canada |
06-07-93 |
VAI-2 |
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08-08-95 |
NAI |
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Janssen Pharm.
Beerse, Belgium |
09-13-93 |
VAI-3 |
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Japan Seigiken Res
Hamamatsu, Shizuoka, Japan |
09-20-93 |
VAI |
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Korea Inst of Toxicology
Korea Res Inst of Chem Tech
Daejeon, Republic of Korea
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12-05-05 |
PEN |
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Lab fur Pharm und Tox
Hamburg, Germany |
01-20-97 |
NAI |
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LAB Preclinical Res International
Laval, Quebec, Canada
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04-05-04 |
NAI |
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Lab of Molecular Endocrin
(LREM)
Cen Hosp Univ Laval (CHUL)
Res Cen
Ste-Foy, Quebec, Canada |
11-04-02 |
OAI |
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Montreal Heart Inst
Montreal, Quebec, Canada |
06-02-03 |
NIM |
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N - |
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Oxo Chemie GmbH
Heidelberg, Germany |
01-13-97 |
OAI |
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RBM Inst (A. Marxer)
Ivrea, Italy |
07-12-93 |
VAI |
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08-21-95 |
NAI |
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Rhone Poulenc Rorer
Vitry sur Seine, France |
08-03-93 |
VAI-2 |
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S - |
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SmithKline Beecham Pharm
Harlow Essex, England |
09-17-93 |
VAI-2 |
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Sterling Winthrop
Northumberland, England |
09-29-93 |
VAI |
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Sterling Research Group
Longvic, France |
07-28-93 |
VAI-2 |
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Syngenta Central Toxicology Lab
fka: Central Toxicology Lab
Cheshire, England |
05-02-00 |
VAI |
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Takeda Chem Industry
Osaka, Japan |
09-05-94 |
VAI |
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Thomae, Karl GmbH
Biberach ander Riss, Germany |
02-08-93 |
NAI |
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Wellcome Research Labs
Beckenham, England |
09-24-93 |
VAI-2 |
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