FDA Warning Letters to Sponsors and Contract Research Organizations

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

• Abbott Laboratories (CDRH) 1998-11-05: http://www.fda.gov/foi/warning_letters/archive/m2164n.pdf
• * Apple Medical Corporation (CDRH) 1998-03-18: http://www.fda.gov/foi/warning_letters/archive/t1505m.pdf
• Aqueous Biomedical, Inc. (CDRH) 2006-11-15: http://www.fda.gov/foi/warning_letters/archive/g6132d.pdf
• Avax Technologies Inc. (CBER) 2001-10-31: http://www.fda.gov/foi/warning_letters/archive/g1925d.pdf
• Avlon Industries (CDER) 2007-01-19: http://www.fda.gov/foi/warning_letters/archive/g6217d.pdf

• Bentec Medical, Inc. (CDRH) 2007-03-21: http://www.fda.gov/foi/warning_letters/b6296d.pdf
• Biotronik Inc. (CDRH) 2004-06-04: http://www.fda.gov/foi/warning_letters/archive/g5064d.pdf
• Birmingham Research Group Inc. (CDER) 2001-08-31: http://www.fda.gov/cder/warn/2001/01-HFD-45-0801.pdf
• Boston Scientic Inc. (CDRH) 2003-08-23: http://www.fda.gov/foi/warning_letters/archive/g4249d.pdf
• Boston Scientic Cardiovascular (CDRH) 2007-08-30: http://www.circare.org/FOIA/bostonscientific_090707.pdf
• BSD Medical Corporation. (CDRH) 2007-03-05: http://www.fda.gov/foi/warning_letters/archive/b6290d.pdf

• Cavitat Medical Technologies, Inc. (CDRH) 2003-09-05: http://www.circare.org/FOIA/fdacmtinc_20030905.pdf (1)
• Cell Point, LLC (CDER) 2006-06-15: http://www.fda.gov/foi/warning_letters/archive/g5932d.pdf
• Celsion Corporation (CDRH) 2004-05-07: http://www.fda.gov/foi/warning_letters/archive/g4759d.pdf
• Center for Research in Sleep Disorders (CDER) 2001-08-30: http://www.fda.gov/cder/warn/2001/01-HFD-45-0802.pdf
• ClinCon Research Incorporated (CDER) 1999-04-09: http://www.fda.gov/foi/warning_letters/archive/m2577n.pdf
• Cochlear Americas (CDRH) 2007-03-13: http://www.fda.gov/foi/warning_letters/archive/b6292d.pdf
• Cordis Inc. (CDRH) 2004-07-07: http://www.fda.gov/foi/warning_letters/archive/g4841d.pdf
• Corin USA (CDRH) 2005-11-22: http://www.fda.gov/foi/warning_letters/archive/g5663d.pdf
• Comprehensive Clinical Research (CDER) 2002-06-05: http://www.fda.gov/cder/warn/2002/02-hfd-45-0301.pdf
• CRS–USA Inc. (CDRH) 1999-08-18: http://www.fda.gov/foi/warning_letters/archive/m2875n.pdf
• Cypress Bioscience Inc. (CDRH) 1999-06-07: http://www.fda.gov/foi/warning_letters/archive/m2685n.pdf

• Discovery Alliance Inc. (CDER) 2001-07-06: http://www.fda.gov/cder/warn/2001/wl45_0701.pdf
  • Related: Patient Advocacy Council, Inc. (CBER) 2007-02-01: http://www.fda.gov/foi/warning_letters/b6314d.pdf
  • Patient Advocacy Council, Inc. Response to FDA. 2007-02-21: http://www.fda.gov/foi/warning_letters/w0082r.pdf
  • FDA Response to Patient Advocacy Council, Inc. 2007-03-16: http://www.fda.gov/foi/warning_letters/w0081r.pdf
• Discovery Experimental & Development Inc. (CDER) 1999-08-16: http://www.fda.gov/cder/warn/aug99/wl99hfd31006.pdf

• Efoora Inc. (CBER) 2005-08-25: http://www.fda.gov/foi/warning_letters/archive/g5477d.pdf
  • Related: Three Executives Indicted in Alleged Fraud Scheme Involving Rapid Diagnostic Tests for HIV, Diabetes and Mad Cow Disease. U.S. Department of Justice Press Release. 2006-05-18: http://www.usdoj.gov/usao/iln/pr/chicago/2006/pr0518_01.pdf
  • United States of America v David Grosky, Craig Rappin, and Melvin Dokich. United States District Court, Northern District of Illinois, Eastern Division. Indictment. 2006-05-18: http://www.usdoj.gov/usao/iln/indict/2006/us_v_grosky_et_al.pdf
• Endomed Inc. (CDRH) 2003-06-03: http://www.fda.gov/foi/warning_letters/archive/g4097d.pdf
• Envita Natural Medical Centers of America (CBER) 2006-06-14: http://www.fda.gov/foi/warning_letters/archive/g5901d.pdf
• Euclid Systems Corporation (CDRH) 2000-04-14: http://www.fda.gov/foi/warning_letters/archive/m3652n.pdf

• Garden State Cancer Center (CBER) 2000-09-19: http://www.fda.gov/foi/warning_letters/archive/m4181n.pdf
• * Genzyme Corporation (CDRH) 1998-07-20: http://www.fda.gov/foi/warning_letters/archive/d1947b.pdf

• Harvard Scientific Corporation (CDER) 1999-05-18: http://www.fda.gov/cder/warn/may99/harvard.pdf
• Heyltex Corporation (CBER) 2000-09-20: http://www.fda.gov/cder/warn/sep2000/dd9-20-00.pdf
  • Related: Form FDA 483 Issued to Paula R. Bickle, Ph.D. 1999-09-08: http://www.circare.org/foia2/483_bickle.pdf

• Imaging Diagnostic Systems, Inc. (CDRH) 2004-01-28: http://www.fda.gov/foi/warning_letters/archive/g4507d.htm
• * IntraCel Corporation (CBER) 1998-10-06: http://www.fda.gov/foi/warning_letters/archive/t2101m.pdf
• Institute for Advanced Clinical Research (CDER) 2000-05-24: http://www.fda.gov/cder/warn/may2000/ci052400.pdf
• International Association for Colon Hydrotherapy (CDRH) 2003-03-21: http://www.fda.gov/foi/warning_letters/archive/g3916d.pdf
• Inter–Os Technologies Incorporated (CDRH) 2003-07-03: http://www.fda.gov/foi/warning_letters/archive/g4176d.pdf

• Jacobson Resonance Enterprises (CDRH) 2001-01-25: http://www.fda.gov/foi/warning_letters/archive/m5147n.pdf (2)
  • Related: America Charitable Fund Inc. Institutional Review Board (CDRH) 2000-12-05: http://www.fda.gov/foi/warning_letters/archive/m4938n.pdf

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• Knoll Pharmaceutical Company (CBER) 1999-03-03: http://www.fda.gov/foi/warning_letters/archive/m2420n.pdf
• KSM, Inc. (CDRH) 2007-03-14: http://www.fda.gov/foi/warning_letters/archive/b6294d.pdf
  • Related: Mystery surrounds activities at former Comanche School. Sharon Roosevelt. Fort Stockton Pioneer. 2006-09-08: http://www.fortstocktonpioneer.com/articles/2006/09/08/news/news01.txt

• LaserSight Technologies, Inc. (CDRH) 1998-05-12: http://www.fda.gov/foi/warning_letters/archive/d1778b.pdf
• ** Laser Therapeutics (CDRH) 2004-10-04: http://www.fda.gov/foi/warning_letters/archive/g4988d.pdf
  • Related: Medicom a.s. (CDRH) 2004-01-12: http://www.fda.gov/foi/warning_letters/archive/g4492d.pdf
• Lifestream Medical Corporation (CDRH) 2005-08-15: http://www.fda.gov/foi/warning_letters/archive/g5442d.pdf

• Medelle Corporation (CDRH) 2005-02-01: http://www.fda.gov/foi/warning_letters/archive/g5456d.pdf
• Medelle Corporation (CDRH) 2006-08-02: http://www.fda.gov/foi/warning_letters/archive/g5971d.pdf
• MedEnclosure, L.L.C. (CDRH) 2007-04-26: http://www.fda.gov/foi/warning_letters/s6354c.pdf
• * MD Anderson Cancer Center. (CBER) 1996-11-07: http://www.fda.gov/foi/warning_letters/archive/d1665b.pdf
• MDS Pharma Services (Bioequivalence Study) 2004-04-26: http://www.fda.gov/cder/warn/2004/MDSPharma.pdf
• MDS Pharma Services (Bioequivalence Studies) 2004-12-21: http://www.fda.gov/cder/warn/2004/mdsuntitledltr.pdf
• MDS Inc. (GLP / Bioequivalence Studies) 2006-08-31: http://www.fda.gov/cder/warn/2006/MDS_Pharma.pdf
  • Related: FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products. FDA Press Release. Rev. 2007-02-01: http://www.fda.gov/cder/news/pharmaco_studies/default.htm
• Medical Device Consulting Inc. (CDRH) 2003-09-03: http://www.fda.gov/foi/warning_letters/archive/g4274d.pdf
• Medical Developmental Research Inc. (CDRH) 1999-12-30: http://www.fda.gov/foi/warning_letters/archive/m3276n.pdf
• Medtronic Vascular (CDRH) 2006-09-27: http://www.fda.gov/foi/warning_letters/archive/g6025d.pdf
• Medtronic Inc. (CDRH) 2000-05-24: http://www.fda.gov/foi/warning_letters/archive/m3790n.pdf
• Medtronic Inc. (CDRH) 1997-12-02: http://www.fda.gov/foi/warning_letters/archive/d747b.pdf
• Midwest Heart Foundation (CDRH) 2004-08-31: http://www.fda.gov/foi/warning_letters/archive/g4937d.pdf

• NEBL Inc. (CDRH) 1999-01-22: http://www.fda.gov/foi/warning_letters/archive/m2344n.pdf

• OASIS Medical Inc. (CDRH) 2005-11-03: http://www.fda.gov/foi/warning_letters/archive/g5580d.pdf
• Orthometrix (CDRH) 2005-07-06: http://www.fda.gov/foi/warning_letters/archive/g5398d.pdf
• Marilyn A. Coleman and Ovimmune (CBER) 2001-07-19: http://www.fda.gov/foi/warning_letters/archive/g1520d.pdf
  • Related: Restitution Ordered for Victims of Unapproved Clinical Trials. FDA Enforcement Story, Center for Biologics Research and Evaluation, 6-4. 2005: http://www.fda.gov/ora/about/enf_story2005_archive/ch6/default.pdf
  • United States of America v. Mitchell V. Kaminski (05-3823); Marilyn A. Coleman (05-3826); and Ovimmune, Inc. (05-4509). Appeal from the United States District Court for the Southern District of Ohio at Columbus. No. 02-00130. 2007-08-31: http://www.ca6.uscourts.gov/opinions.pdf/07a0356p-06.pdf
  • Ovimmune Informed Consent use of egg yolk containing natural antibodies against candida albicans/tropicalis. Undated: http://www.circare.org/FOIA/ovimmune_consent.pdf (3)
  • Egg Powder Key Ingredient in Legal Fight. David Lore. The Columbus Dispatch. 2002-11-11: http://pro-networkers.com/bbs/messages/10116.html

• Paradigm Medical Industries Inc. (CDRH) 2000-08-30: http://www.fda.gov/foi/warning_letters/archive/m4116n.pdf
• * Plus Orthopedics (CDRH) 2003-10-03: http://www.fda.gov/foi/warning_letters/archive/g4331d.pdf
• PharmaKinetics Laboratories (CDER) 1999-07-27: http://www.fda.gov/cder/warn/july99/wl_072799_pkl.pdf
• Presby Corp (CDRH) 2000-01-07: http://www.fda.gov/foi/warning_letters/archive/m3329n.pdf

• ReGen Biologics (CDRH) 2005-09-15: http://www.fda.gov/foi/warning_letters/archive/g5481d.pdf
• Replidyne, Inc. (CDER) 2008-02-15: http://www.fda.gov/cder/warn/2008/08-HFD-45-0117.pdf

• Saliva Diagnostic Systems Inc. (CBER) 2005-08-25: http://www.fda.gov/foi/warning_letters/archive/g5478d.pdf
• Sanofi-Aventis U.S. LLC. (CDER) 2007-10-23: http://www.fda.gov/cder/warn/2007/07-HFD-45-1002.pdf
  • Follow this link for additional information on clinical trials conducted by Sanofi-Aventis for Ketek™
• * Scimed Life Sciences Inc., Boston Scientific Corp. (CDRH) 1998-07-23: http://www.fda.gov/foi/warning_letters/archive/d1967b.pdf
• SciOptic International (CDRH) 2001-07-09: http://www.fda.gov/foi/warning_letters/archive/g1482d.pdf
• Shelhigh, Inc. (CDRH) 2005-12-14: http://www.fda.gov/foi/warning_letters/archive/g5674d.htm
• Silimed Incorporated (CDRH) 2003-08-21: http://www.fda.gov/foi/warning_letters/archive/g4267d.pdf
• Silimed Incorporated (CDRH) 2007-04-27: http://www.fda.gov/foi/warning_letters/s6346c.pdf
• STAAR Surgical (CDRH) 2004-04-23: http://www.fda.gov/foi/warning_letters/archive/g4655d.pdf
• ** STAAR Surgical Company (CDRH) 2007-06-27: http://www.fda.gov/foi/warning_letters/s6418c.pdf
• Stimsoft Inc. (CDRH) 2003-10-23: http://www.fda.gov/foi/warning_letters/archive/g4375d.pdf
• SunCoast Medical Group Inc. (CDRH) 1996-11-07: http://www.fda.gov/foi/warning_letters/archive/d1644b.pdf
• Surgilight Inc. (CDRH) 2004-06-01: http://www.fda.gov/foi/warning_letters/archive/g4750d.pdf
• SyntheMed Inc. (CDRH) 2008-02-19: http://www.fda.gov/foi/warning_letters/s6673c.pdf

• TMJ Implants Inc. (CDRH) 2000-09-20: http://www.fda.gov/foi/warning_letters/archive/m4212n.pdf
• Titan Pharmaceuticals, Inc. (CBER) 2002-04-15: http://www.fda.gov/foi/warning_letters/archive/g3180d.pdf

• University of Cincinnati College of Medicine. (CDRH) 2007-01-29: http://www.fda.gov/foi/warning_letters/archive/s6431c.pdf
• Uroplasty Inc. (CDRH) 2005-07-19: http://www.fda.gov/foi/warning_letters/archive/g5415d.pdf

• Wingrove, Frank A., D.D.S. (CDER) 2007-06-22: http://www.fda.gov/foi/warning_letters/s6457c.pdf
• Wright Medical Technology Inc. (CDRH) 2004-05-14: http://www.fda.gov/foi/warning_letters/archive/g4760d.pdf

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Sources:
FDA Archived Warning Letters Search November 1996 to April 2006
FDA Warning Letters Index 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

CDRH: Center for Devices and Radiological Health re: objecionable conduct in research testing a medical device.
CDER: Center for Drug Evaluation and Research re: objectionable conduct in research testing a drug.
CBER: Center for Biologic Evaluation and Research re: objectionable conduct in research testing a biologic.

Notes

1. Cavitat Medical Technologies, Inc. and Robert J. Jones vs. Aetna, Inc. Case No. 04CV01849. Exhibit, Plaintiff's Response to Motion to Bifurcate or, Alternatively, Reset the Trial Date. 2005-12-28. United States District Court for the District of Colorado.

2. Clinical Investigator Warned for Promoting an Investigational Device on the Internet. FDA Enforcement Story, Center for Devices and Radiological Health, 2. 2001: http://www.fda.gov/ora/about/enf_story/archive/2001/ch2/default.htm

3. Marilyn A. Coleman and Ovimmune, Inc. v. Sally W. Wiley et al. Case No. 2002CV0048. Common Pleas Court Union County, Ohio. Complaint (Exhibit A). 2002-02-21: http://www.circare.org/FOIA/2002cv0048_complaint.pdf

Last Updated: 2008-03-29

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