FDA Warning Letters to Institutional Review Boards

Follow this link to find more information about FDA warning letters
Follow this link for an overview of FDA warning letters by year and type

America Charitable Fund Inc. Institutional Review Board (CDRH) 2000-12-05: http://www.fda.gov/foi/warning_letters/archive/m4938n.pdf
Atlantic Medical Center (CDRH, SUSP) 1999-06-23: http://www.fda.gov/foi/warning_letters/archive/m2731n.pdf

Baltimore City Health Department Institutional Review Board (CBER) 2005-12-15: http://www.fda.gov/foi/warning_letters/archive/g5667d.pdf
Baptist Health System (CDER; SUSP) 1997-10-23: http://www.fda.gov/foi/warning_letters/archive/m311n.pdf
Bayshore Community Hospital (CDRH) 2001-07-28: http://www.fda.gov/foi/warning_letters/archive/g1527d.pdf
Brookhaven Memorial Hospital Medical Center Institutional Review Board (CDRH) 2008-07-08: http://www.fda.gov/foi/warning_letters/s6870c.pdf

Catholic Health Partners (CBER, SUSP) 2002-12-09: http://www.fda.gov/foi/warning_letters/archive/g3746d.pdf
Central Florida Eye Institute Institutional Review Board (CDRH) 2004-07-12: http://www.fda.gov/foi/warning_letters/archive/g4839d.pdf
Clifton Springs Hospital and Clinic (SUSP) 1997-09-15: http://www.fda.gov/foi/warning_letters/archive/m428n.pdf
Coast Institutional Review Board (CDER, SUSP) 2008-03-11: http://www.fda.gov/cder/warn/2008/08-HFD-45-1101.pdf
The Cooper Health System (CDRH) 2000-08-30: http://www.fda.gov/foi/warning_letters/archive/m4119n.pdf
Christus St. Patrick Hospital (CBER) 2000-08-29: http://www.fda.gov/foi/warning_letters/archive/m4142n.pdf
Crittenton Hospital Medical Center Institutional Review Board (CDRH) 2002-11-07: http://www.fda.gov/foi/warning_letters/archive/g3665d.pdf
Crittenton Hospital Medical Center Institutional Review Board (CDRH) 2005-01-19: http://www.fda.gov/foi/warning_letters/archive/g5168d.pdf

Downey Regional Medical Center Institutional Review Committee (CDRH) 2004-06-16: http://www.fda.gov/foi/warning_letters/archive/g4774d.pdf

Essex Institutional Review Board (CDER, SUSP, PEDS) 1998-08-27: http://www.fda.gov/foi/warning_letters/archive/t1989m.pdf
- Related: Acevedo, Eduardo Caro M.D. (CDER, NIDPOE) 1998-08-28: http://www.fda.gov/foi/nidpoe/n18l.pdf
- Debarment Order issued to Eduardo Caro Acevedo, M.D. 2005-03-24: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-5781.pdf
Essex Institutional Review Board (CBER, PEDS) 2000-03-01: http://www.fda.gov/foi/warning_letters/archive/m3448n.pdf
- Related: Notice of Initiation of Disqualification Proceedings and Opportunity to Explain issued to Peter K. Law, Ph.D. 2000-06-30: http://www.fda.gov/foi/nidpoe/n9l.pdf
- Notice of Opportunity for Hearing issued to Peter K. Law, Ph.D. 2002-11-01: http://www.fda.gov/foi/nooh/law.pdf
- Notice of Disqualification to Receive lnvestigational New Drugs issued to Peter K. Law, Ph.D. 2006-10-26: http://www.fda.gov/foi/clinicaldis/peterlaw.html

F.F. Thompson Healthcare Systems, Inc. Institutional Review Board (CDER, SUSP) 1998-04-14: http://www.fda.gov/foi/warning_letters/archive/d1735b.pdf
Fairview Hospital Institutional Review Board, Cleveland Clinic Health System (CDRH) 2003-05-14: http://www.fda.gov/foi/warning_letters/archive/g4035d.pdf
Family Medical Center Institutional Review Board (CDRH) 1999-08-30: http://www.fda.gov/foi/warning_letters/archive/m2927n.pdf
Franklin Hospital Medical Center Investigational Drug Committee (CDER, SUSP) 1998-10-05: http://www.fda.gov/foi/warning_letters/archive/m2082n.pdf
Freeport Health Network Institutional Review Board (CDRH) 2007-03-14: http://www.fda.gov/foi/warning_letters/archive/b6293d.pdf

Galesburg Institutional Review Board (CBER) 2006-05-25: http://www.fda.gov/foi/warning_letters/archive/g5884d.pdf
Great Lakes College of Clinical Medicine Institutional Review Board (CBER, SUSP) 2000-03-09: http://www.circare.org/foia2/fda_glccm20000309.pdf
- Related: Form FDA 483. L. Terry Chappell M.D. and Great Lakes Association of Clinical Medicine Institutional Review Board. 1994-12-21: http://www.circare.org/foia2/483_glccm19941221.pdf
- Form FDA 483. L. Terry Chappell M.D. and Great Lakes College of Clinical Medicine Institutional Review Board. 1999-12-01: http://www.circare.org/foia2/483_glccm19991201.pdf
- FDA Establishment Inspection Report. Great Lakes College of Clinical Medicine Institutional Review Board. 1999-12-01: http://www.circare.org/foia2/glccm_fdaeir19991201.pdf
Griffin Hospital Institutional Review Board (CDRH) 2000-03-24: http://www.fda.gov/foi/warning_letters/archive/m3585n.pdf

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Kaweah Delta Health Care District Institutional Review Committee (CDRH) 2004-05-04: http://www.fda.gov/foi/warning_letters/archive/g4682d.pdf

Hialeah Hospital Institutional Review Board (CDRH) 2002-03-18: http://www.fda.gov/foi/warning_letters/archive/g3150d.pdf
Henrico Doctor's Hospital Institutional Review Board (CDRH) 2004-08-30: http://www.fda.gov/foi/warning_letters/archive/g4940d.pdf
- Henrico Doctor's Hospital Institutional Review Board Response to FDA. 2004-09-13: http://www.fda.gov/foi/warning_letters/archive/w0029r.pdf
Hilton Head Medical Center and Clinics Institutional Review Board (CBER) 1996-12-23: http://www.fda.gov/foi/warning_letters/archive/d1689b.pdf
Holy Cross Hospital Institutional Review Board (CDRH) 2000-09-26: http://www.fda.gov/foi/warning_letters/archive/m4252n.pdf
Human Investigation Committee of Texas (CDER) 2006-01-23: http://www.fda.gov/cder/warn/2006/06-HFD-45-0120.pdf
Huntsville Hospital Institutional Review Committee (CDRH) 2003-04-11: http://www.fda.gov/foi/warning_letters/archive/g3945d.pdf
Huntsville Hospital Institutional Review Committee (CDRH) 2005-08-01: http://www.fda.gov/foi/warning_letters/archive/g5426d.pdf

ImmunoGenetics Institutional Review Board (CBER, SUSP, PEDS) 2001-08-13: http://www.fda.gov/foi/warning_letters/archive/g1613d.pdf

Kaiser Foundation Hospitals Northern California Institutional Review Board (CDER, SUSP) 1999-07-22: http://www.fda.gov/foi/warning_letters/archive/t1936m.pdf

International Bio-Oxidative Medicine Foundation Inc. Institutional Review Board (CDER, SUSP) 1997-06-02: http://www.fda.gov/foi/warning_letters/archive/m962n.pdf
Irvine Regional Hospital and Medical Center Institutional Review Board (CBER) 2002-06-14: http://www.fda.gov/foi/warning_letters/archive/g3353d.pdf

Lake Charles Memorial Hospital Institutional Review Board (CDRH) 2003-05-27: http://www.fda.gov/foi/warning_letters/archive/g4048d.pdf
Louisiana State University Medical Center Institutional Review Board (CDRH) 1999-03-12: http://www.fda.gov/foi/warning_letters/archive/m3216n.pdf
Lovelace Institutional Review Board (CDRH) 2003-02-27: http://www.fda.gov/foi/warning_letters/archive/g3840d.pdf

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MD Anderson Cancer Center (CDER) 2006-06-15: http://www.fda.gov/foi/warning_letters/archive/g5930d.pdf
MedEnclosure, L.L.C. (CBER) 2007-04-26: http://www.fda.gov/foi/warning_letters/archive/s6354c.pdf
Mission Bay Memorial Hospital Institutional Review Board (CDRH) 2000-03-14: http://www.fda.gov/foi/warning_letters/archive/m3651n.pdf

Nevada Institutional Review Board (CBER) 2007-07-11: http://www.fda.gov/cber/compl/nvirb071107.htm
- Related: Gallagher SE. Snake Oil Salesman Hit Jackpot in Nevada. Accessed on 2007-11-01 at: http://faculty.uml.edu/sgallagher/NIRB.htm
New York Eye and Ear Infirmary (CDRH) 2003-12-11: http://www.fda.gov/foi/warning_letters/archive/g4449d.pdf
North Texas Institutional Review Board (CBER, SUSP) 2003-04-14: http://www.fda.gov/foi/warning_letters/archive/g3960d.pdf
- Related: Antibody Systems Incorporated. Citizen's Petition 2005P-0182: Withdraw April 14, 2003 Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA. 2005-05-06. Available from http://www.fda.gov/ohrms/dockets/dockets/05p0182/05p-0182-cp00001-toc.htm
- Form FDA 483. Neil N. Dishon M.D. and North Texas Institutional Review Board. 2002-12-17: http://www.fda.gov/ohrms/dockets/dockets/05p0182/05p-0182-cp00001-Tab-05-vol1.pdf
- FDA Establishment Inspection Report. North Texas Institutional Review Board. 2002-12-17: http://www.fda.gov/ohrms/dockets/dockets/05p0182/05p-0182-cp00001-Tab-04-vol1.pdf
Northeast Georgia Medical Center Inc. Institutional Review Board (CBER) 2000-03-25: http://www.fda.gov/foi/warning_letters/archive/m3719n.pdf

Oak Lawn Institutional Review Board (CDRH) 2003-09-17: http://www.fda.gov/foi/warning_letters/archive/g4304d.pdf
- Oak Lawn Institutional Review Board Response to FDA, 2003-09-26: http://www.fda.gov/foi/warning_letters/archive/w0006r.pdf
- Oak Lawn Institutional Review Board Response to FDA. 2004-01-26: http://www.fda.gov/foi/warning_letters/archive/w0007r.pdf
Ochsner Clinical Foundation Institutional Review Board (CDRH, SUSP) 2002-03-05: http://www.fda.gov/foi/warning_letters/archive/g3138d.pdf
Oklahoma Blood Institute Institutional Review Board (CBER) 2006-07-10: http://www.fda.gov/foi/warning_letters/archive/g5938d.pdf
Our Lady of Lourdes Medical Center Institutional Review Board (CDRH) 1999-03-11: http://www.fda.gov/foi/warning_letters/archive/m2460n.pdf
Outpatient Surgery Center for Sight Institutional Review Board (CDRH) 2000-02-25: http://www.fda.gov/foi/warning_letters/archive/m3433n.pdf

Pacific University College of Optometry Institutional Review Board (CDRH) 2003-01-14: http://www.fda.gov/foi/warning_letters/archive/g3785d.pdf
Patient Advocacy Council, Inc. (CBER) 2007-02-01: http://www.fda.gov/foi/warning_letters/archive/b6314d.pdf
- Patient Advocacy Council, Inc. Response to FDA. 2007-02-21: http://www.fda.gov/foi/warning_letters/archive/w0082r.pdf
- FDA Response to Patient Advocacy Council, Inc. 2007-03-16: http://www.fda.gov/foi/warning_letters/archive/w0081r.pdf

Queen of the Valley Hospital Institutional Reviewing Committee (CDRH) 1999-06-07: http://www.fda.gov/foi/warning_letters/archive/m2676n.pdf

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Siems Advanced Lasik Center Institutional Review Board (CDRH, SUSP) 2004-04-05: http://www.fda.gov/foi/warning_letters/archive/g4614d.pdf
Shepherd Eye Center Institutional Review Board (CDRH) 1999-08-11: http://www.fda.gov/foi/warning_letters/archive/m2860n.pdf **
Southern Connecticut State University Institutional Review Board (CDRH) 1999-10-11: http://www.fda.gov/foi/warning_letters/archive/m3198n.pdf
St. Anthony Memorial Health Center Institutional Review Board (CDER, SUSP) 2001-10-12: http://www.fda.gov/foi/warning_letters/archive/g1851d.pdf
St. Elizabeth Medical Center Institutional Review Board (CDRH) 2007-05-08: http://www.fda.gov/foi/warning_letters/archive/s6359c.pdf
St. Francis Hospital Inc. Institutional Review Board (CDER, SUSP) 1997-12-03: http://www.fda.gov/foi/warning_letters/archive/m600n.pdf
St. Francis Medical Center Institutional Review Board (CDRH) 2000-08-14: http://www.fda.gov/foi/warning_letters/archive/m4069n.pdf
St. John's Hospital and Medical CenterInstitutional Review Board (CDRH) 2005-06-23: http://www.fda.gov/foi/warning_letters/archive/g5382d.pdf
St. Joseph's Healthcare Institutional Review Board (CDRH) 2006-11-07: http://www.fda.gov/foi/warning_letters/archive/g6118d.pdf
St. Mary's Medical Center Institutional Review Board (CDRH) 2001-03-07: http://www.fda.gov/foi/warning_letters/archive/m5249n.pdf
Stanislaus Surgical Hospital Institutional Review Board (CDRH) 2004-05-27: http://www.fda.gov/foi/warning_letters/archive/g4752d.pdf
State University of New York Institutional Review Board (CBER) 1997-07-17: http://www.fda.gov/foi/warning_letters/archive/m639n.pdf

Texas Applied Biotechnology Research Review Committee (CDRH) 2000-09-27: http://www.fda.gov/foi/warning_letters/archive/m4233n.pdf

University of Colorado Colorado Multiple Institutional Review Board [COMIRB] (CBER, SUSP) 1999-09-13: http://www.fda.gov/foi/warning_letters/archive/m2948n.pdf
University of Iowa Institutional Review Board (CDRH) 1999-06-28: http://www.fda.gov/foi/warning_letters/archive/m2868n.pdf
University of South Florida Health Science Center Institutional Review Boards 01 and 01B (CDRH) 1999-11-10: http://www.fda.gov/foi/warning_letters/archive/m3199n.pdf

Vail Valley Medical Center Institutional Review Board (CDRH) 2006-06-22: http://www.fda.gov/foi/warning_letters/archive/g5903d.pdf
Valley Hospital Medical Center Institutional Review Board (CBER) 1997-02-18: http://www.fda.gov/foi/warning_letters/archive/d1198b.pdf
Virginia Commonwealth University Institutional Review Board (CDRH, SUSP) 1999-08-12: http://www.fda.gov/foi/warning_letters/archive/m2861n.pdf
Virginia Mason Research Center Institutional Review Board (CBER) 1999-09-23: http://www.fda.gov/foi/warning_letters/archive/m2975n.pdf

Washington Regional Medical Center Institutional Review Board (CDRH) 2006-12-08: http://www.fda.gov/foi/warning_letters/archive/g6203d.pdf
West Jefferson Medical Center IRB (CDER, PEDS) 2008-02-25: http://www.fda.gov/cder/warn/2008/08-HFD-45-0204.pdf
Wheaton Franciscan Healthcare Joint Institutional Review Board #1 (CBER) 2007-01-24: http://www.fda.gov/foi/warning_letters/archive/g6219d.pdf

Key
PEDS: one or more studies enrolled children.
SUSP: suspension of institutional review board (IRB) authority to review and approve new research subject to FDA regulations.
CBER: Center for Biologics Evaluation and Research.
CDER: Center for Drug Evaluation and Research.
CDRH: Center for Devices and Radiological Health.

Sources:
FDA Archived Warning Letter and Response Search: November 1996 to March 2006
FDA Warning Letters Indexed by Date: March 2006 to present

Warning Letter: A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions. FDA Center for Drug Evaluation and Research, Division of Scientific Investigations. Accessed on 2006-03-19 at: http://www.fda.gov/cder/Offices/DSI/enforcement.htm

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Last Updated: 2008-08-05

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