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FDA's Electronic Reading Room - Warning Letters



Warning Letters Search Results


Search Criteria: Office is "Center for Drug Evaluation and Research"
   
21st Century Sports Nutritionals, Inc.  06/13/2002  Center for Drug Evaluation and Research  Synthetic Ephedrine Alkaloids/New Drug   No   
2bbrands.com/drugstore  09/09/2003  Center for Drug Evaluation and Research  New Drug/Labeling/False Promotional Statements/Misbranded   No   
3M Center  10/19/2006  Center for Drug Evaluation and Research  Labeling/Promotional Claims False & Misleading Claims/New Drug/Misbranded   No   
4nRx/Hong Kong  10/22/1999  Center for Drug Evaluation and Research  Drug Marketing/Unapproved Prescription Drugs   No   
4nRx/New Zealand  10/22/1999  Center for Drug Evaluation and Research  Drug Marketing/Unapproved Prescription Drugs   No   
ABL - Antibiotics Do Brasil  07/24/2009  Center for Drug Evaluation and Research  CGMP/Adulterated  No   
ACS Dobfar  07/21/2005  Center for Drug Evaluation and Research  Current Good Manufacturing Practice Regulation/Adulterated   No   
Actavis Totowa LLC  02/26/2007  Center for Drug Evaluation and Research  Marketing an unapproved new drug - ergotamine tartrate   No   
Actelion Pharmaceuticals US, Inc.  07/20/2005  Center for Drug Evaluation and Research  Labeling/Promotional Claims False & Misleading   No   
Actelion Pharmaceuticals US, Inc.  11/24/2008  Center for Drug Evaluation and Research  DDMAC/Promotional Claims False & Misleading/Misbranded   No   
Adelglass Jeffrey M. M.D.  05/25/1999  Center for Drug Evaluation and Research  Clinical Investigator  No   
Aerosol Science Laboratories Inc.  10/29/2008  Center for Drug Evaluation and Research  False & Misleading Claims/New Drug/Misbranded   No   
Akyuz, Sinan  11/16/2009  Center for Drug Evaluation and Research  Unapproved New Drug/Misbranded   No   
Akyuz, Sinan  11/16/2009  Center for Drug Evaluation and Research  Unapproved New Drug/Misbranded   No   
Alaven Pharmaceutical LLC  07/13/2009  Center for Drug Evaluation and Research  Federal Food, Drug, and Cosmetic Act Violations/Misleading   No   
Alcon Laboratories, Inc.  04/20/2007  Center for Drug Evaluation and Research  DDMAC/Promotional Claims False & Misleading/Misbranded   No   
Alcon Laboratories, Inc.  04/27/2005  Center for Drug Evaluation and Research  Promotional Claims/False & Misleading/Misbranded   No   
Alcon, Inc.  10/20/2006  Center for Drug Evaluation and Research  Labeling/Promotional Claims False & Misleading Claims/New Drug/Misbranded   No   
Aliachem A.S.  01/15/2004  Center for Drug Evaluation and Research  Good Manufacturing Practices/Active Pharmaceutical Ingredients/Adulterated   No   
Allergan, Inc.  05/25/2007  Center for Drug Evaluation and Research  DDMAC  No   
Allergan, Inc.  09/06/2005  Center for Drug Evaluation and Research  Labeling/Promotional Claims False & Misleading/Misbranded   No   
Allscripts Healthcare Solutions  10/11/2002  Center for Drug Evaluation and Research  Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin   No   
Alphagen Laboratories Inc.  10/11/2002  Center for Drug Evaluation and Research  Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin   No   
Amato, Robert J., D.O.  09/18/2007  Center for Drug Evaluation and Research  Bioresearch Monitoring Program/IRB   No   
Ambi Pharmaceuticals  10/11/2002  Center for Drug Evaluation and Research  Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin   No   
American Health Foundation  06/06/1997  Center for Drug Evaluation and Research  GLP  No   
American Histolabs, Inc.  11/29/2001  Center for Drug Evaluation and Research  GLP for Non-Clinical Laboratory Studies   No   
Amerisource Health Services Corp.  10/11/2002  Center for Drug Evaluation and Research  Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin   No   
Amide Pharmaceutical Inc.  10/11/2002  Center for Drug Evaluation and Research  Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin   No   
Amrita Aromatherapy, Inc  05/28/2009  Center for Drug Evaluation and Research  Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus   No   
Anabolic Inc.  10/11/2002  Center for Drug Evaluation and Research  Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin   No   
Anabolic Laboratories  02/26/2007  Center for Drug Evaluation and Research  Marketing an unapproved new drug - ergotamine tartrate   No   
Apotex Inc.  06/25/2009  Center for Drug Evaluation and Research  CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated   No   
Ashland Drug  04/09/2002  Center for Drug Evaluation and Research  Nicotine Lollipops/New Drug/Misbranded   No   
Avlon Industries  01/19/2007  Center for Drug Evaluation and Research  Bioresearch Monitoring Program/IRB   No   
B.F. Ascher & Company, Inc.  10/16/2001  Center for Drug Evaluation and Research  Labeling/Unapproved New Drug/Misbranded   No   
BDI Pharmaceuticals  02/24/1997  Center for Drug Evaluation and Research  Drug Products/Weight Loss  No   
BUZZ, LLC  11/16/2009  Center for Drug Evaluation and Research  Unapproved New Drug/Misbranded   No   
Baptist Health System  10/23/1997  Center for Drug Evaluation and Research  IRB (Institutional Review Board)   No   
Bayer HealthCare - Bayer Schering Pharma AG  08/05/2009  Center for Drug Evaluation and Research  CGMP for Deviations/Adulterated   No   
Bayer HealthCare LLC  10/27/2008  Center for Drug Evaluation and Research  Drug Labeling/Promotional Claims/Misbranded   No   
Bayer HealthCare LLC  10/27/2008  Center for Drug Evaluation and Research  Drug Labeling/Promotional Claims/Misbranded   No   
Bayer HealthCare Pharmaceuticals, Inc.  10/03/2008  Center for Drug Evaluation and Research  DDMAC/Promotional Claims False & Misleading/Misbranded   No   
Better Bodies  06/13/2002  Center for Drug Evaluation and Research  Synthetic Ephedrine Alkaloids/New Drug   No   
Beutler Ernest M.D.  04/30/1999  Center for Drug Evaluation and Research  Clinical Investigator  No   
Bigmar-Bioren SA  08/03/2004  Center for Drug Evaluation and Research  Current Good Mfg Practice Regulations/Adulterated   No   
Bio Pharm Inc.  02/26/2007  Center for Drug Evaluation and Research  Marketing an unapproved new drug - ergotamine tartrate   No   
BioMarin Pharmaceutical Inc.  10/11/2006  Center for Drug Evaluation and Research  Labeling/Promotional Claims False & Misleading   No   
Bird's Hill Pharmacy  04/09/2002  Center for Drug Evaluation and Research  Nicotine Lollipops/New Drug/Misbranded   No   
Bishop, Clark M.D.  06/07/2005  Center for Drug Evaluation and Research  Clinical Investigator  No   

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