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Office of Scientific Investigations Warning Letters
Current OSI Warning Letters
OSI Warning Letters Archive (1997-2011)
| Company/Individual | Inspection Type | Date Letter Issued |
|---|---|---|
| 2012 Warning Letters | ||
| 2011 Warning Letters | ||
| 2010 | ||
| Howard L. Lippton, MD | Clinical Investigator | 10/20/10 |
| David F. Scott, MD | Clinical Investigator | 10/20/10 |
| Thomas O'Barr, Jr, MD | Clinical Investigator | 9/30/10 |
| Lamar L. Snow, MD | Clinical Investigator | 9/29/10 |
| Joel Picus, MD | Clinical Investigator | 9/20/10 |
| Bay Regional Medical Center | Institutional Review Board | 9/9/10 |
| SNBL USA Ltd | GLP for non-clinical laboratory studies | 8/9/10 |
| Ephraim McDowell Regional Medical Center | Institutional Review Board | 4/26/10 |
| Brookwood Medical Center | Institutional Review Board | 4/22/10 |
| Pfizer, Inc | Sponsor/Applicant/Monitor/Contract Research Organization | 4/9/10 |
| Robert Dietz, MD | Clinical Investigator | 4/1/10 |
| Sant P. Chawla, MD | Clinical Investigator | 3/17/10 |
| Henry Lin, MD | Sponsor/Investigator | 3/8/10 |
| Timothy Summers, MD | Clinical Investigator | 2/24/10 |
| Sohail Punjwani, MD | Clinical Investigator | 2/4/10 |
| 2009 | ||
| John A. Ward, MD | Clinical Investigator | 12/3/09 |
| ICON Clinical Research | Sponsor/Applicant/Monitor/Contract Research Organization | 11/27/09 |
| Craig M. Buettner, MD | Clinical Investigator | 11/24/09 |
| Thomas Gazda, MD | Clinical Investigator | 11/24/09 |
| Anthony Dallas, MD | Clinical Investigator | 11/9/09 |
| Charles McKay, MD | Clinical Investigator | 10/23/09 |
| MI Hope Inc. dba Center for Complex Infectious Diseases | Institutional Review Board | 10/19/09 |
| Burzynski Research Institute | Institutional Review Board | 10/5/09 |
| Johnson and Johnson Pharmaceutical Research and Development | Sponsor/Applicant/Monitor/Contract Research Organization | 8/10/09 |
| Christus Schumpert Health System | Institutional Review Board | 7/30/09 |
| Barbara Harris, PhD | Clinical Investigator | 7/27/09 |
| Mark Gordon, MD | Clinical Investigator | 6/26/09 |
| Noli R. Zosa, MD | Clinical Investigator | 6/16/09 |
| Coast | Institutional Review Board | 4/14/09 |
| Ronald Bukowski, MD | Clinical Investigator | 3/30/09 |
| Manuel J. Quinones, MD | Clinical Investigator | 3/3/09 |
| Charles J. Cote, MD | Clinical Investigator | 3/2/09 |
| Virenda Desai, MD | Clinical Investigator | 3/2/09 |
| SUNY Downstate Medical Center, Health Science Center | Institutional Review Board | 2/11/09 |
| Nicola Spirtos, MD | Clinical Investigator | 1/3/09 |
| 2008 | ||
| Richard Holub, MD | Clinical Investigator | 10/1/08 |
| Hospital Municipal de San Juan | Institutional Review Board | 8/15/08 |
| Travanti Pharma Inc | Sponsor/Applicant/Monitor/Contract Research Organization | 6/30/08 |
| Nagarjuna R. Ponugoti, MD | Clinical Investigator | 6/6/08 |
| Willa Hsueh, MD | Sponsor/Investigator | 5/30/08 |
| Arturo Corces, MD | Clinical Investigator | 5/28/08 |
| Edward Mostel, MD | Clinical Investigator | 5/16/08 |
| Saroj Brar, MD | Clinical Investigator | 3/20/08 |
| Ashok Shah, MD | Clinical Investigator | 3/19/08 |
| Coast | Institutional Review Board | 3/11/08 |
| Frank Whittier, MD | Clinical Investigator | 3/6/08 |
| West Jefferson Medical Center | Institutional Review Board | 2/25/08 |
| Kevin W. Klein, MD | Clinical Investigator | 2/13/08 |
| Nasim Golzar, MD | Clinical Investigator | 2/13/08 |
| Replidyne, Inc | Sponsor/Applicant/Monitor/Contract Research Organization | 1/18/08 |
| 2007 | ||
| Surenda Chaganti, MD | Clinical Investigator | 10/27/07 |
| Sanofi Aventis U.S. | Sponsor/Applicant/Monitor/Contract Research Organization | 10/23/07 |
| Robert J. Amato, DO | Clinical Investigator | 9/18/07 |
| Sitek Research Laboratories | GLP for non-clinical laboratory studies | 6/25/07 |
| Frank A. Wingrove, DDS | Sponsor/Investigator | 6/22/07 |
| David H. Vesole, MD, PhD | Clinical Investigator | 5/30/07 |
| David Linden, MD | Clinical Investigator | 5/22/07 |
| Robert M. Murray, MD | Clinical Investigator | 2/28/07 |
| Hollis J.C. Underwood, MD | Clinical Investigator | 2/15/07 |
| Jerry M. Herron, MD | Clinical Investigator | 2/13/07 |
| Avlon Industries | Sponsor/Applicant/Monitor/Contract Research Organization | 1/19/07 |
| Lawrence S. Kim, MD | Clinical Investigator | 1/16/07 |
| 2006 | ||
| E. Clinton Lawrence, MD | Clinical Investigator | 11/16/06 |
| Herman Zaharowitz, MD | Clinical Investigator | 8/31/06 |
| MDS Pharma, Inc | Bioequivalence | 8/31/06 |
| Professor Olga D. Ostroumova | Clinical Investigator | 8/18/06 |
| Evangeline G. Gonzalez, MD | Clinical Investigator | 7/6/06 |
| Cell Point LLC | Sponsor/Applicant/Monitor/Contract Research Organization | 6/15/06 |
| Massimo Cristofanilli, MD | Clinical Investigator | 6/15/06 |
| MD Anderson Cancer Center | Institutional Review Board | 6/15/06 |
| North American Science Association Inc | GLP for non-clinical laboratory studies | 5/11/06 |
| Human Investigation Committee of Houston, TX | Institutional Review Board | 1/23/06 |
| 2005 | ||
| Raymond E. Tidman, MD | Clinical Investigator | 12/19/05 |
| ITT Research Institute | GLP for non-clinical laboratory studies | 12/5/05 |
| Spencer B. Jones, MD | Clinical Investigator | 10/27/05 |
| Litron Laboratories Ltd | GLP for non-clinical laboratory studies | 7/1/05 |
| Clark Bishop, MD | Sponsor/Investigator | 6/7/05 |
| Gene Logic Inc | GLP for non-clinical laboratory studies | 1/28/05 |
| 2004 | ||
| MDS Pharma Services | Bioequivalence | 12/21/04 |
| Celsis Laboratory Group | GLP for non-clinical laboratory studies | 11/29/04 |
| MDS Pharma Services | Bioequivalence | 4/26/04 |
| 2003 | ||
| William Sokol, MD | Clinical Investigator | 5/27/03 |
| Alkis Togias, MD | Sponsor/Investigator | 3/31/03 |
| 2002 | ||
| Leonard J. Caputo, MD | Clinical Investigator | 6/11/02 |
| David R. Hassman, MD | Clinical Investigator | 6/5/02 |
| 2001 | ||
| American Histolabs | GLP for non-clinical laboratory studies | 11/29/01 |
| St. Anthony Memorial Health Center | Institutional Review Board | 10/12/01 |
| Coulston Foundation | GLP for non-clinical laboratory studies | 10/11/01 |
| Toxicology Research Laboratories | GLP for non-clinical laboratory studies | 10/4/01 |
| Martin B. Scharf, PhD | Sponsor/Investigator | 8/30/01 |
| William M. Patterson, MD | Clinical Investigator | 8/30/01 |
| Peter Krumpe, MD | Clinical Investigator | 7/31/01 |
| Candace S. Brown, PharmD, FNP | Clinical Investigator | 7/25/01 |
| Catawba Memorial Hospital | Institutional Review Board | 7/16/01 |
| Northern Westchester Hospital Center | Institutional Review Board | 7/6/01 |
| Lori A. Nesbitt, PharmD, MBA, Gulf Coast Clinical Services | Clinical Investigator | 7/6/01 |
| 2000 | ||
| Jeffrey R. Levenson, MD | Clinical Investigator | 9/27/00 |
| Heyltex Corporation | Sponsor/Investigator | 9/20/00 |
| Anne L. Macek, MD / Howard S. Cummins, PhD | Clinical Investigators | 5/24/00 |
| Scott M. Dorfner, DO | Clinical Investigator | 4/7/00 |
| Cal K. Cohn, MD | Clinical Investigator | 3/29/00 |
| 1999 | ||
| Coulston Foundation | GLP for non-clinical laboratory studies | 12/22/99 |
| WIL Research Laboratories, Inc. | GLP for non-clinical laboratory studies | 11/26/99 |
| PharmaKinetics Laboratories, Inc. | Bioequivalence | 7/27/99 |
| Jeffrey M. Adelglass, MD | Clinical Investigator | 5/25/99 |
| Bruce Ettinger, MD | Clinical Investigator | 5/19/99 |
| Philip B. Gorelick, MD, MPH | Clinical Investigator | 5/19/99 |
| Harvard Scientific Corporation | Sponsor/Applicant/Monitor/Contract Research Organization | 5/18/99 |
| ClinCon Research, Inc. | Sponsor/Applicant/Monitor/Contract Research Organization | 4/9/99 |
| 1998 | ||
| Donald E. Johnson, MD | Clinical Investigator | 12/17/98 |
| FF Thompson Healthcare Systems, Inc. | Institutional Review Board | 4/14/98 |
| Parkash S. Gill, MD | Clinical Investigator | 2/20/98 |
| Abdollah Iravani, MD | Clinical Investigator | 2/18/98 |
| 1997 | ||
| St. Francis Hospital | Institutional Review Board | 12/3/97 |
| Baptist Health System | Institutional Review Board | 10/23/97 |
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Note: Some Warning Letters may not yet be posted to this archive site and therefore the totals may not match those found in the OSI Metric Slides.
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