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FDA's Electronic Reading Room - Warning Letters



Warning Letters Search Results


Search Criteria: Response Letter Posted is either "Yes" or "No" and Has Closeout Letter is "Yes"
   
3TP LLC  10/05/2004  Center for Devices and Radiological Health  Premarket Approval/Misbranded  No   
ASK Foods, Inc  03/28/2006  Philadelphia District Office  CGMP for Foods/Seafood HACCP/Adulterated   No   
Advanced Reproductive Laboratory  01/09/2007  Dallas District Office  Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products   No   
Allez Spine, LLC  08/08/2008  Los Angeles District Office  CGMP/QSR/Medical Devices/Adulterated   No   
Americell-labs.com VMG Global Inc  07/27/2009  San Francisco District Office  Dietary Supplements/Adulterated/Misbra nded   No   
Brede, Inc.  08/21/2008  Detroit District Office  CGMP/Deviations For Food Manufacturers/Adulterated   No   
Capital Foods, Inc.  01/06/2003  New Jersey District Office  CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated   No   
Chocolate Cottage, Inc.  04/25/2006  Denver District Office  Labeling/Misbranded  No   
Chung's Products, LP  10/30/2007  Dallas District Office  Seafood HACCP/Adulterated  No   
Cote, Charles J., MD  03/02/2009  Center for Drug Evaluation and Research  Clinical Investigator  No   
Criado, Frank J. M.D.  06/19/2003  Center for Devices and Radiological Health  Clinical Investigator  No   
Customs Scripts Pharmacy  12/04/2006  Florida District Office  Pharmacy Compounding/New Drug/Misbranded   No   
Del-Immune V  01/26/2006  Denver District Office  Labeling/Promotional Claims False & Misleading/New Drug   No   
Electro Therapeutic Devices, Inc.  04/05/2004  Center for Devices and Radiological Health  QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterat ed   No   
G.T. Laboratories  08/31/2004  Chicago District Office  Quality System Regulation/Adulterated   No   
GlycoMeds, LLC  05/19/2009  Center for Food Safety and Applied Nutrition  Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus   No   
Gulf Marine & Industrial Supplies, Inc.  04/27/2005  New Orleans District Office  Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Adulterated   No   
Hain Celestial Group, Inc.  08/17/2007  Center for Food Safety and Applied Nutrition  Dietary Supplement/Adulterated   No   
Health Dimensions, Inc.  11/27/2006  Detroit District Office  Pharmacy Compounding/New Drug/Misbranded   No   
Henrico Doctor's Hospital IRB  08/30/2004  Center for Devices and Radiological Health  Institutional Review Board  No   
Hohmann, Elizabeth L., M.D.  07/10/2006  Center for Biologics Evaluation and Research  Clinical Investigator  No   
Honey Smoked Fish Company LLC  06/26/2000  Denver District Office  Seafood Processing Regulations/HACCP   No   
Honolulu Fish & Seafood Corporation  11/28/2006  San Francisco District Office  CGMP for Foods/Seafood HACCP/Adulterated   No   
Houchin Blood Services  09/21/2005  San Francisco District Office  Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated   No   
L.A.G. Sales Company  05/16/2000  New York District Office  Imported Canned Coffee/Entry Not Held Intact   No   
Leiner Health Products, LLC  08/28/2007  Atlanta District Office  CGMP for Finished Pharmaceuticals/Deviations/Adu lterated   No   
Lifecore Biomedical, Inc.  10/08/2004  Center for Devices and Radiological Health  Medical Device Reporting/Misbranded   No   
Lincare, Inc.  12/09/2004  New Orleans District Office  Pharmacy Compounding/Misbranded   No   
Lordex Inc  12/29/2003  Dallas District Office  Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation   No   
Love and Quiches, Ltd.  07/20/2004  New York District Office  Interstate Conveyance Sanitation/GMP Mfr, Packing, Holding Food   No   
Lydall, Inc.  05/27/2005  Atlanta District Office  CGMP/Adulterated  No   
Massachusetts Institute of Technology  06/15/2004  Center for Devices and Radiological Health  Good Laboratory Practices  No   
Medina General Hospital  09/17/2002  Cincinnati District Office  Mammography Quality Standards  No   
Medron, Inc.  12/03/2003  Denver District Office  Quality System Reguation/Adulterated   No   
Michael S. Miller, D.O.  02/12/2008  Center for Biologics Evaluation and Research  Investigational Device Exemptions (Clinical Investigator)   No   
Natural Ovens of Manitowoc Inc  04/08/2003  Minneapolis District Office  Food Labeling/Misbranded  No   
NatureMost of New England  08/09/2002  New England District Office  New Drug/Labeling/Misbranded  No   
Nelson Crab, Inc.  09/02/2004  Seattle District Office  Seafood HACCP/Adulterated  No   
New Wave Seafood, Inc.  11/25/2002  New England District Office  Seafood HACCP  No   
Nichols, Trent M.D.  02/24/2005  Center for Devices and Radiological Health  Clinical Investigator  No   
North American Medical Corporation  03/02/2007  Atlanta District Office  CGMP/QSR/Medical Devices/Adulterated/Misbranded   No   
OST Medical, Inc.  07/19/2004  New England District Office  Lacks Premarket Approval/Adulterated/Misbrande d   No   
Oak Lawn Institutional Review Board  09/17/2003  Center for Devices and Radiological Health  Institutional Review Board  No   
Obsidian Medical Technology Inc.  02/24/2004  San Francisco District Office  Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated   No   
Our Lady of the Lake Hospital, Inc.  05/07/2004  New Orleans District Office  GMP for Blood & Blood Components/Adulterated   No   
Pacific Northwest Best Fish Company  07/19/2005  Seattle District Office  Seafood HACCP/Adulterated  No   
Pacifica Pharmacy  01/07/2008  Los Angeles District Office  New Drug/False Misleading/Labeling/Misbranded   No   
Panbio, Inc.  10/05/2005  Baltimore District Office  Lacks Premarket Approval Application/Misbranded   No   
Patient Advocacy Council, Inc.  02/01/2007  Center for Biologics Evaluation and Research  Institutional Review Board  No   
Peak Performance Foods, LLC  05/03/2004  Cincinnati District Office  Food Labeling/Misbranded  No   
Pharmachem Laboratories, Inc.  11/19/2004  New Jersey District Office  Dietary Supplement/Labeling/False & Misleading Claims/Misbranded   No   
Preferred Freezer Services, Inc.  06/26/2007  New Jersey District Office  Seafood HACCP/Adulterated  No   
Professional Hair Institute, Inc.  10/13/2005  Baltimore District Office  Lacks Approved New Drug Application/Misbranded   No   
Pyng Medical Corporation  04/09/2004  Center for Devices and Radiological Health  Medical Device Reporting/Misbranded   No   
Rapid Recovery Health Services Inc.  03/07/2005  Center for Devices and Radiological Health  Lacks Premarket Approval/Adulterated/Misbrande d   No   
Reed's Compounding Pharmacy  01/07/2008  Los Angeles District Office  New Drug/False Misleading/Labeling/Misbranded   No   
Reichel Foods, LLC  09/16/2003  Minneapolis District Office  Food Labeling/New Drugs/Misbranded   No   
Restorative Products, Inc.  12/02/2005  Florida District Office  Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbran ded   No   
Revival Animal Health, Inc.  11/21/2005  Kansas City District Office  Promotional Claims False & Misleading/Adulterated/Misbran ded   No   
Rezai, Ali R, M.D  11/13/2008  Center for Devices and Radiological Health  Clinical Investigator  No   
Riverside Medical Clinic, Inc.  11/06/2002  Los Angeles District Office  Mammography Quality Standards  No   
SCM True Air Technologies LLC  09/24/2007  Cincinnati District Office  CGMP/QSR/Medical Devices/Adulterated   No   
Safer Sleep, LLC  05/27/2008  New Orleans District Office  CGMP/QSR/Medical Devices/Adulterated   No   
Safie Specialty Foods Co., Inc  03/20/2009  Detroit District Office  Acidified Foods/Adulterated  No   
Sam Rust Seafood Inc.  04/05/2006  Baltimore District Office  Seafood HACCP/Adulterated  No   
Sansone's Seafood Market, Inc.  07/08/2004  Philadelphia District Office  Seafood HACCP/Adulterated  No   
Scientific Botanicals Co., Inc.  05/21/2004  Seattle District Office  Dietary Supplement Regulations/Misbranded   No   
SeniorLife Health Inc.  08/21/2008  Los Angeles District Office  New Drug/Labeling/False & Misleading Claims   No   
Siegel, Robert M., M.D.  05/27/2004  Center for Devices and Radiological Health  Clinical Investigator  No   
Skaggs, David, M.D.  02/14/2003  Center for Devices and Radiological Health  Institutional Review Board  No   
Southside Community Hospital  12/09/2003  Baltimore District Office  Blood & Blood Products/Adulterated   No   
Sunder Biomedical Tech Co.  04/23/2004  Center for Devices and Radiological Health  Quality System Regulation/Adulterated   No   
TMJ Implants, Inc.  12/20/2006  Center for Devices and Radiological Health  Lacks Premarket Approval Application/Adulterated/Misbra nded   No   
TYA Pharmaceuticals  08/06/2002  Florida District Office  CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated   No   
Tembec, Inc.  09/11/2007  Cincinnati District Office  Food Additive/Adulterated/Misbrande d   No   
Tidman, Raymond E., M.D.  12/19/2005  Center for Drug Evaluation and Research  Clinical Investigator  No   
Troy Innovative Instruments, Inc.  11/01/2007  Cincinnati District Office  CGMP for Medical Devices/QS/Adulterated   No   
University Pharmacy  12/04/2006  Denver District Office  Pharmacy Compounding/New Drug/Misbranded   No   
Village Compounding Pharmacy  01/07/2008  Dallas District Office  New Drug/False Misleading/Labeling/Misbranded   No   
Vision Chips Inc  04/14/2003  Los Angeles District Office  Quality System Reguation/Adulterated   No   
Weese-Mayer, Debra E., M.D.  10/14/2005  Center for Devices and Radiological Health  Clinical Investigator  No   
Western United Fish Company, Inc.  05/16/2008  Seattle District Office  Seafood HACCP/CGMP for Foods/Adulterated   No   

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