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Form FDA 483s

Notice: if there has been a substantive change in matters described in FDA warning letters we will gladly update our information. Please use the Webmaster email link at the bottom of this page to contact us.

We post warning letters to clinical investigators, sponsors, and institutional review boards (IRBs) issued by the United States Food and Drug Administration (FDA) on the CIRCARE web site. Prior to mid-2009 we provided links to these documents on the FDA website. We repeatedly corrected hundreds of links but after the FDA website revision in 2009 we decided to post relevant warning letters on our website to conserve resources while keeping these documents in the public eye. Although we make good faith efforts to monitor FDA warning letters we cannot guarantee matters have not changed. Therefore visitors should consult the FDA website for the most current information. The main FDA warning letter webpage is available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Visitors may wish to consult FDA's list of warning letters with closeout letters at: http://tinyurl.com/78k39vu

FDA provides additional information about warning letters at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#moreinfo

From time to time FDA reorganizes its website. Before you contact us to say that FDA "rescinded" your warning letter please use the Warning Letter search on the FDA website: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Please review our Terms of Use for important information about material posted on the CIRCARE web site.

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


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.


Last Updated: 2012-02-11

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