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Office of Scientific Investigations Warning Letters

 

Current OSI Warning Letters

 

OSI Warning Letters Archive (1997-2011)  

Company/Individual Inspection TypeDate Letter Issued
2012 Warning Letters
2011 Warning Letters
2010
Howard L. Lippton, MDClinical Investigator10/20/10
David F. Scott, MDClinical Investigator10/20/10
Thomas O'Barr, Jr, MDClinical Investigator9/30/10
Lamar L. Snow, MDClinical Investigator9/29/10
Joel Picus, MDClinical Investigator9/20/10
Bay Regional Medical CenterInstitutional Review Board9/9/10
SNBL USA LtdGLP for non-clinical laboratory studies8/9/10
Ephraim McDowell Regional Medical CenterInstitutional Review Board4/26/10
Brookwood Medical CenterInstitutional Review Board4/22/10
Pfizer, IncSponsor/Applicant/Monitor/Contract Research Organization4/9/10
Robert Dietz, MDClinical Investigator4/1/10
Sant P. Chawla, MDClinical Investigator3/17/10
Henry Lin, MDSponsor/Investigator3/8/10
Timothy Summers, MDClinical Investigator2/24/10
Sohail Punjwani, MDClinical Investigator2/4/10
2009
John A. Ward, MDClinical Investigator12/3/09
ICON Clinical ResearchSponsor/Applicant/Monitor/Contract Research Organization11/27/09
Craig M. Buettner, MDClinical Investigator11/24/09
Thomas Gazda, MDClinical Investigator11/24/09
Anthony Dallas, MDClinical Investigator11/9/09
Charles McKay, MDClinical Investigator10/23/09
MI Hope Inc. dba Center for Complex Infectious DiseasesInstitutional Review Board10/19/09
Burzynski Research InstituteInstitutional Review Board10/5/09
Johnson and Johnson Pharmaceutical Research and DevelopmentSponsor/Applicant/Monitor/Contract Research Organization8/10/09
Christus Schumpert Health SystemInstitutional Review Board7/30/09
Barbara Harris, PhDClinical Investigator7/27/09
Mark Gordon, MDClinical Investigator6/26/09
Noli R. Zosa, MDClinical Investigator6/16/09
CoastInstitutional Review Board4/14/09
Ronald Bukowski, MDClinical Investigator3/30/09
Manuel J. Quinones, MDClinical Investigator3/3/09
Charles J. Cote, MDClinical Investigator3/2/09
Virenda Desai, MDClinical Investigator3/2/09
SUNY Downstate Medical Center, Health Science CenterInstitutional Review Board2/11/09
Nicola Spirtos, MDClinical Investigator1/3/09
2008
Richard Holub, MDClinical Investigator10/1/08
Hospital Municipal de San JuanInstitutional Review Board8/15/08
Travanti Pharma IncSponsor/Applicant/Monitor/Contract Research Organization6/30/08
Nagarjuna R. Ponugoti, MDClinical Investigator6/6/08
Willa Hsueh, MDSponsor/Investigator5/30/08
Arturo Corces, MDClinical Investigator5/28/08
Edward Mostel, MDClinical Investigator5/16/08
Saroj Brar, MDClinical Investigator3/20/08
Ashok Shah, MDClinical Investigator3/19/08
CoastInstitutional Review Board3/11/08
Frank Whittier, MDClinical Investigator3/6/08
West Jefferson Medical CenterInstitutional Review Board2/25/08
Kevin W. Klein, MDClinical Investigator2/13/08
Nasim Golzar, MDClinical Investigator2/13/08
Replidyne, IncSponsor/Applicant/Monitor/Contract Research Organization1/18/08
2007
Surenda Chaganti, MDClinical Investigator10/27/07
Sanofi Aventis U.S. Sponsor/Applicant/Monitor/Contract Research Organization10/23/07
Robert J. Amato, DOClinical Investigator9/18/07
Sitek Research LaboratoriesGLP for non-clinical laboratory studies6/25/07
Frank A. Wingrove, DDSSponsor/Investigator6/22/07
David H. Vesole, MD, PhDClinical Investigator5/30/07
David Linden, MDClinical Investigator5/22/07
Robert M. Murray, MDClinical Investigator2/28/07
Hollis J.C. Underwood, MDClinical Investigator2/15/07
Jerry M. Herron, MDClinical Investigator2/13/07
Avlon IndustriesSponsor/Applicant/Monitor/Contract Research Organization1/19/07
Lawrence S. Kim, MDClinical Investigator1/16/07
2006
E. Clinton Lawrence, MDClinical Investigator11/16/06
Herman Zaharowitz, MDClinical Investigator8/31/06
MDS Pharma, IncBioequivalence8/31/06
Professor Olga D. OstroumovaClinical Investigator8/18/06
Evangeline G. Gonzalez, MDClinical Investigator7/6/06
Cell Point LLCSponsor/Applicant/Monitor/Contract Research Organization6/15/06
Massimo Cristofanilli, MDClinical Investigator6/15/06
MD Anderson Cancer CenterInstitutional Review Board6/15/06
North American Science Association IncGLP for non-clinical laboratory studies5/11/06
Human Investigation Committee of Houston, TXInstitutional Review Board1/23/06
2005
Raymond E. Tidman, MDClinical Investigator12/19/05
ITT Research InstituteGLP for non-clinical laboratory studies12/5/05
Spencer B. Jones, MDClinical Investigator10/27/05
Litron Laboratories LtdGLP for non-clinical laboratory studies7/1/05
Clark Bishop, MDSponsor/Investigator6/7/05
Gene Logic IncGLP for non-clinical laboratory studies1/28/05
2004
MDS Pharma ServicesBioequivalence12/21/04
Celsis Laboratory GroupGLP for non-clinical laboratory studies11/29/04
MDS Pharma ServicesBioequivalence4/26/04
2003
William Sokol, MDClinical Investigator5/27/03
Alkis Togias, MDSponsor/Investigator3/31/03
2002
Leonard J. Caputo, MDClinical Investigator6/11/02
David R. Hassman, MDClinical Investigator6/5/02
2001
American HistolabsGLP for non-clinical laboratory studies11/29/01
St. Anthony Memorial Health CenterInstitutional Review Board10/12/01
Coulston FoundationGLP for non-clinical laboratory studies10/11/01
Toxicology Research LaboratoriesGLP for non-clinical laboratory studies10/4/01
Martin B. Scharf, PhDSponsor/Investigator8/30/01
William M. Patterson, MDClinical Investigator8/30/01
Peter Krumpe, MDClinical Investigator7/31/01
Candace S. Brown, PharmD, FNPClinical Investigator7/25/01
Catawba Memorial HospitalInstitutional Review Board7/16/01
Northern Westchester Hospital CenterInstitutional Review Board7/6/01
Lori A. Nesbitt, PharmD, MBA, Gulf Coast Clinical ServicesClinical Investigator7/6/01
2000
Jeffrey R. Levenson, MDClinical Investigator9/27/00
Heyltex CorporationSponsor/Investigator9/20/00
Anne L. Macek, MD / Howard S. Cummins, PhDClinical Investigators

5/24/00

Scott M. Dorfner, DOClinical Investigator4/7/00
Cal K. Cohn, MDClinical Investigator3/29/00
1999
Coulston FoundationGLP for non-clinical laboratory studies12/22/99
WIL Research Laboratories, Inc.GLP for non-clinical laboratory studies11/26/99
PharmaKinetics Laboratories, Inc.Bioequivalence7/27/99
Jeffrey M. Adelglass, MDClinical Investigator5/25/99
Bruce Ettinger, MDClinical Investigator5/19/99
Philip B. Gorelick, MD, MPHClinical Investigator5/19/99
Harvard Scientific CorporationSponsor/Applicant/Monitor/Contract Research Organization5/18/99
ClinCon Research, Inc.Sponsor/Applicant/Monitor/Contract Research Organization4/9/99
1998
Donald E. Johnson, MDClinical Investigator12/17/98
FF Thompson Healthcare Systems, Inc.Institutional Review Board4/14/98
Parkash S. Gill, MDClinical Investigator2/20/98
Abdollah Iravani, MDClinical Investigator2/18/98
1997
St. Francis HospitalInstitutional Review Board12/3/97
Baptist Health SystemInstitutional Review Board10/23/97

 

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