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U.S. Department of Health and Human Services

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2009 Warning Letters

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Warning Letters issued in 2009

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
09/28/2009 Drugs Are Us, Inc. [ARCHIVED] Center for Drug Evaluation and Research Active Pharmaceutical Ingredient/Adulterated Not Issued *
09/28/2009 Zanzibar Cafe, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP Not Issued *
09/25/2009 Trans-Caribbean Dairy Corporation 9/25/09 [ARCHIVED] San Juan District Office Juice HACCP/Adulterated Not Issued *
09/23/2009 Orval Kent Food Company, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP Not Issued *
09/23/2009 Platinum Strategies, Inc. [ARCHIVED] Detroit District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded 07/07/2010
09/21/2009 Mountain Meadow Herbs, Inc [ARCHIVED] Seattle District Office Labeling/New Drug/Misbranded Not Issued *
09/18/2009 Advanced Medical Optics Uppsala Ab [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 12/20/2011
09/15/2009 Mu Kung Hwa Oriental Foods, LLC [ARCHIVED] Seattle District Office CGMP Regulation For Food/Adulterated Not Issued *
09/15/2009 Kirkwood, John M., MD [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator 05/28/2010
09/15/2009 Kohinoor Foods, Inc. [ARCHIVED] Baltimore District Office CGMP/Manufacturing Packing & Holding Human Food/Misbranded Not Issued *
09/14/2009 SKW Ventures, LLC [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
09/14/2009 Pyramid Sprouters [ARCHIVED] Minneapolis District Office Adulterated Food 06/02/2011
09/14/2009 Viraban [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
09/14/2009 Setton Pistachio of Terra Bella, Inc. [ARCHIVED] San Francisco District Office CGMP/Prepared, Packed, or held under insanitary Conditions/Adulterated Not Issued *
09/11/2009 Ocean Hyperbaric Center [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
09/11/2009 Customed, Inc [ARCHIVED] San Juan District Office CGMP/QSR/Medical Devices/Adulterated 09/02/2010
09/11/2009 Cumberland Farms, Inc. [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated 02/25/2010
09/11/2009 La Hacienda Tortilleria Inc [ARCHIVED] New Orleans District Office CGMP Regulation For Food/Adulterated Not Issued *
09/11/2009 Schlegel Dairy Farms Inc [ARCHIVED] Cincinnati District Office Illegal Drug Residue Not Issued *
09/11/2009 Luv N' Care Ltd [ARCHIVED] New Orleans District Office Medical Devices/Adulterated/Misbranded Not Issued *
09/11/2009 NETPRODUCTSTORE INC, DBA Afton Communications [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
09/10/2009 United Metro Distribution Co. 9/10/09 [ARCHIVED] Detroit District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
09/10/2009 Pelican Packers, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
09/10/2009 Baxter Healthcare Corp. [ARCHIVED] Chicago District Office Medical Devices/Adulterated/Misbranded 04/05/2012
09/09/2009 Lloyd T. Smith & Sons [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
09/09/2009 Border Foods, Incorporated [ARCHIVED] Denver District Office Acidified Foods/Adulterated 12/01/2010
09/09/2009 Witmer Foods, Inc. [ARCHIVED] Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated 06/08/2011
09/09/2009 Ferris, Henry J. [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
09/09/2009 Szarek, Francis J [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
09/04/2009 Gambro Dialysatoren, GmbH [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
09/04/2009 Pressure-Tech, Inc. [ARCHIVED] New York District Office Premarket Approval/Misbranded/Adulterated Not Issued *
09/03/2009 Pantheon Research 9/3/09 [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
09/03/2009 Supplements To WeightLoss, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
09/02/2009 Solafeet, Inc [ARCHIVED] Center for Devices and Radiological Health Radiological Health/Records & Report/Performance Standards Not Issued *
09/01/2009 Beekman Foods Inc [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated 04/15/2010
09/01/2009 WHB Cattle LLC 9/1/09 [ARCHIVED] Dallas District Office Illegal Drug Residue Not Issued *
08/31/2009 Therasage, LLC. [ARCHIVED] Florida District Office Medical Devices/Adulterated/Misbranded N/A *
08/28/2009 Marlen Manufacturing & Development Co. [ARCHIVED] Cincinnati District Office CGMP/QSR/Adulterated/Misbranded N/A *
08/28/2009 HG Early - Snyder Family Farm LLC [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
08/28/2009 J & L Dairy [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
08/27/2009 Folsum Metal Products, Inc. dba FRONTIER DEVICES [ARCHIVED] New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
08/26/2009 Cooley Dickinson Hospital, BB [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
08/26/2009 Very Fresh Juice Company [ARCHIVED] Cincinnati District Office Food Labeling/Adulterated N/A *
08/26/2009 Yon's Foods LLC [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded N/A *
08/25/2009 CHS Nutrition [ARCHIVED] Seattle District Office CGMP for Licensed Medicated Feeds/Adulterated N/A *
08/25/2009 Evenflo Company Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
08/25/2009 Tib Molbiol [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
08/25/2009 Washington Homeopathic Products, Inc. [ARCHIVED] Baltimore District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
08/24/2009 Sumitomo Chemical Co., Ltd. 8/24/09 [ARCHIVED] Center for Drug Evaluation and Research CGMP/Adulterated N/A *
08/21/2009 ANIP Acquisition Company [ARCHIVED] New Orleans District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded N/A *

 

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