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Form FDA 483s

Form FDA 483 Issued to Paula R. Bickle Ph.D., Cascade Consultants Research Foundation. 1999-09-08 [DMPS IND trials sponsored by Heyltex Inc.]: http://www.circare.org/foia2/483_bickle.pdf

Form FDA 483 Issued to Richard L. Borison M.D. 1997-04-22: http://www.bioethicswatch.org/foia/borison483_19970422.pdf

Form FDA 483 Issued to Richard L. Borison M.D. 1993-06-24: http://www.bioethicswatch.org/foia/borison483_19930624.pdf

Form FDA 483 Issued to L. Terry Chappell M.D., Great Lakes College of Clinical Medicine Institutional Review Board. 1999-12-01: http://www.circare.org/foia2/483_glccm19991201.pdf

Form FDA 483 Issued to L. Terry Chappell M.D., Great Lakes Association of Clinical Medicine Institutional Review Board. 1994-12-21: http://www.circare.org/foia2/483_glccm19941221.pdf

Form FDA 483 Issued to Arnold E. Eggers M.D., SUNY Health Sciences Center. 1995-04-19: http://www.bioethicswatch.org/foia/483_eggers.pdf

Form FDA 483 Issued to James A. Holland M.D., Stratton VA Medical Center. 2003-01-02: http://www.bioethicswatch.org/foia/strattonva483_20030102.pdf

Form FDA 483 Issued to Kevin L. Keim Ph.D., Quintiles Pacific, Inc. 1999-01-13 [NDA 20-823 Novartis Exelon]: http://www.bioethicswatch.org/foia/quintiles483_19990113.pdf

El-Hage, A. Correspondence to Kevin L. Keim Ph.D., Quintiles Pacific, Inc. 1999-08-16 [NDA 20-823 Novartis Exelon]: http://www.circare.org/exelon/fda_quintiles_19990816.pdf (1)

Form FDA 483 Issued to Lisa A. Krinsky, SFBC International Inc. 2005-05-02: http://www.bioethicswatch.org/foia/sfbcinternational483_20050502.pdf (2)

Form FDA 483 Issued to Lisa A. Krinsky, SFBC International Inc. 2004-09-15: http://www.bioethicswatch.org/foia/sfbcinternational483_20040915.pdf (2)

Form FDA 483 Issued to Lisa A. Krinsky, SFBC International Inc. 2004-07-23: http://www.bioethicswatch.org/foia/sfbcinternational483_20040723.pdf (2)

Form FDA 483 Issued to Carl R. Lang, M.D., Greater Northwest Medical Group. 2002-12-30 [Ketek™ protocol #3014]: http://www.circare.org/FOIA/lang_fda483_20021230.pdf

Meredith Rigdon Lentz, M.D. Form FDA 483 2001-05-10: http://www.circare.org/fdaeirs/lentz_fda483_20010510.pdf

Meredith Rigdon Lentz, M.D. FDA Establishment Inspection Report 2001-05-10: http://www.circare.org/fdaeirs/lentz_fdaeir_20010510.pdf

For additional information see the FDA warning letter to Dr. Lentz: http://www.circare.org/FOIA/fdawarninglettersftol.htm#l

Form FDA 483 Issued to Antonio R. Pizarro M.D., SFBC Fort Myers. 2005-06-03: http://www.bioethicswatch.org/foia/sfbcinternational483_20050603.pdf (2)

Form FDA 483 Issued to Alkis Togias M.D., Johns Hopkins Asthma & Allergy Clinic. 2001-06-28 [Death of Ellen Roche]: http://www.circare.org/fdawls3/togias483_20010628.pdf

Johns Hopkins University Response to FDA. 2001-07-16: http://www.circare.org/fdawls3/togias_fdareply_20010721.pdf

Form FDA 483 Issued to Johns Hopkins School of Medicine Institutional Review Board. 2001-09-07 [Death of Ellen Roche]: http://www.circare.org/fdawls3/jhuirb_483.pdf

Form FDA 483 Issued to Johns Hopkins Bayview Medical Center Human Subjects Committee. 2001-09-07 [Death of Ellen Roche]: http://www.circare.org/fdawls3/bayviewmc_483.pdf

More Forms FDA 483: FDA Office of Regulatory Affairs ORA Electronic Reading Room


Notes

1. NDA 20-823 Novartis Exelon, Administrative Documents and Correspondence. Accessed on 2007-06-01 at: http://www.fda.gov/cder/foi/nda/2000/20823_Exelon_admincorres.pdf

2. FDA Forms 483 related to SFBC International, Inc., courtesy of John Dorschner and The Miami Herald.


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Last Updated: 2010-07-27

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