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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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
05/11/2011 Do-n-Joy Holsteins [ARCHIVED] Minneapolis District Office Illegal Drug Residue Not Issued *
05/09/2011 Omar Seafood, Corp [ARCHIVED] Florida District Office Seafood HACCP/Adulterated Not Issued *
05/09/2011 Saemrow Dairy [ARCHIVED] Minneapolis District Office Illegal Drug Residue 10/17/2011
05/09/2011 Zuccaros Fruit and Produce Company, Inc. [ARCHIVED] Minneapolis District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 08/14/2012
05/06/2011 Ten Tea [ARCHIVED] San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded Not Issued *
05/06/2011 Inez Mattison New York District Office Illegal Drug Residue Not Issued *
05/06/2011 ADAO, Inc. [ARCHIVED] Denver District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
05/06/2011 Green Hope LLC dba Rosewood [ARCHIVED] Detroit District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
05/06/2011 Ten Ren Tea Company of San Francisco, Ltd [ARCHIVED] San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded Not Issued *
05/05/2011 Christus Spohn Hospital Corpus Christi - Memorial Campus [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
05/05/2011 LifeCell Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
05/05/2011 Tiny Greens [ARCHIVED] Chicago District Office Unsanitary Conditions/Adulterated Not Issued *
05/05/2011 Alpha Laboratories, Inc. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 08/06/2012
05/05/2011 Evanger's Dog & Cat Food Company, Inc. [ARCHIVED] Chicago District Office Low Acid Canned Foods/Adulterated/Misbranded 02/28/2013
05/04/2011 Southeast Asian Food Product [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/04/2011 Venus Pharmaceuticals International, Inc. [ARCHIVED] New York District Office Current Good Manufacturing Practice for Dietary Supplements Not Issued *
05/04/2011 God's Garden Pharmacy [ARCHIVED] Los Angeles District Office CGMP/Dietary Supplement Not Issued *
05/02/2011 Valley Wholesale Produce and Seafood [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated Not Issued *
05/02/2011 Dani Jacq, Inc [ARCHIVED] Baltimore District Office CGMP for Foods/Seafood HACCP/Adulterated 09/05/2012
05/02/2011 Le Natural, Inc. [ARCHIVED] San Juan District Office Labeling Drug Claims Not Issued *
04/29/2011 Standard Homeopathic Company, Inc. [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
04/28/2011 Great Oriental Food Products [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 06/21/2011
04/28/2011 Viruxo.com [ARCHIVED] Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
04/28/2011 Flor Nutraceuticals, LLC [ARCHIVED] Dallas District Office New Drug/Misbranded Not Issued *
04/28/2011 Captain's Fine Foods, LLC [ARCHIVED] Florida District Office CGMP for Foods/Seafood HACCP/Adulterated 09/13/2011
04/28/2011 Premier Micronutrient Corporation [ARCHIVED] New Orleans District Office Labeling Drug Claims Not Issued *
04/28/2011 Medavir Medical Advances, Inc. [ARCHIVED] Florida District Office New Drug/Misbranded Not Issued *
04/28/2011 Chlamydia-clinic.com [ARCHIVED] San Francisco District Office Drug Products/Therapeutic Claims Not Issued *
04/28/2011 Everclr3 [ARCHIVED] Seattle District Office Drug Products/Therapeutic Claims Not Issued *
04/28/2011 Immuneglory.com [ARCHIVED] San Francisco District Office New Drug/Misbranded Not Issued *
04/28/2011 Derma Remedies [ARCHIVED] Center for Drug Evaluation and Research New Drug/Misbranded Not Issued *
04/28/2011 Lesa Sverid [ARCHIVED] New England District Office Drug Products/Therapeutic Claims Not Issued *
04/28/2011 Polydna [ARCHIVED] New York District Office Drug Products/Therapeutic Claims Not Issued *
04/28/2011 Pacific Naturals [ARCHIVED] Los Angeles District Office New Drug/Misbranded Not Issued *
04/28/2011 Master Peace Inc [ARCHIVED] Cincinnati District Office Drug Products/Therapeutic Claims Not Issued *
04/28/2011 International Institute of Holistic Healing Inc. [ARCHIVED] Dallas District Office New Drug/Misbranded Not Issued *
04/28/2011 Generic Medical Devices, Inc. [ARCHIVED] Seattle District Office Premarket Approval/Misbranded/Adulterated 07/29/2011
04/27/2011 Intelli Health Products, LLC [ARCHIVED] Florida District Office Promotional Claims/New Drug/Misbranded Not Issued *
04/26/2011 La Placita Botanas Mexicanus, Inc. [ARCHIVED] Los Angeles District Office CGMP/Misbranded Not Issued *
04/26/2011 Golden State Medical Supply, Inc. [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated 04/19/2012
04/26/2011 Guangxi Jisheng Foods Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 06/30/2011
04/26/2011 Dangjin Food Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
04/25/2011 Cephazone Pharma LLC [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated 06/21/2012
04/25/2011 Natural Path / Silver Wings, LLC [ARCHIVED] New Orleans District Office CGMP/Unapproved New Drug/Dietary Supplement/Adulterated/Misbranded Not Issued *
04/22/2011 Healthcare Authority of the City of Demopolis [ARCHIVED] New Orleans District Office Mammography Quality Standards Act Not Issued *
04/22/2011 Solar Wide Industrial Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/Quality System, Promotion and Advertsing, and Device Registration Not Issued *
04/22/2011 Solar Wide Industrial Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
04/22/2011 ZOLL Medical Corporation [ARCHIVED] New England District Office CGMP for Medical Devices/QS/Adulterated 04/23/2012
04/21/2011 American Contract Systems [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated 01/05/2012
04/21/2011 Tufo's To Go, LLC [ARCHIVED] Cincinnati District Office Interstate Conveyance Sanitation Regulations 08/24/2011

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