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2005 Warning Letters

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Tobacco Retailer Warning Letters

 

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* 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
12/29/2005 Edgar Martin Dairy [ARCHIVED] Minneapolis District Office Illegal Drug Residue /Adulterated N/A *
12/27/2005 Wellness Resources, Inc. [ARCHIVED] Minneapolis District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
12/23/2005 Fujian Sky Food Company [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
12/23/2005 Siouxland Community Blood Bank [ARCHIVED] Kansas City District Office Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated N/A *
12/22/2005 Fukumaru Seafood Company [ARCHIVED] Los Angeles District Office Seafood HACCP N/A *
12/22/2005 Paradise Farm Corporation [ARCHIVED] New England District Office Juice HACCP/Adulterated N/A *
12/22/2005 Guidant Corporation [ARCHIVED] Minneapolis District Office CGMP for Medical Devices/QS/Adulterated N/A *
12/21/2005 Dore, David D., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
12/21/2005 Gold Eagle Cooperative [ARCHIVED] Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
12/21/2005 Clarkdale Fruit Farms Inc. [ARCHIVED] New England District Office Juice HACCP N/A *
12/21/2005 Lawsons Farm [ARCHIVED] New England District Office Illegal Drug Residue /Adulterated N/A *
12/19/2005 Tidman, Raymond E., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
12/16/2005 Midwest Seafood, Inc. [ARCHIVED] Cincinnati District Office Seafood HACCP/Adulterated N/A *
12/16/2005 Seecor, Inc. [ARCHIVED] Dallas District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
12/15/2005 Baltimore City Health Department [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
12/14/2005 Topway Enterprises, Inc. [ARCHIVED] Dallas District Office CGMP Regulations for Foods/Seafood (HACCP) N/A *
12/14/2005 Shelhigh, Inc. [ARCHIVED] New Jersey District Office CGMP Requirement for Medical Devices/Lacks Premarket Approval Application/Adulterated N/A *
12/13/2005 Ise Newberry, Inc. [ARCHIVED] Atlanta District Office Control of Communicable Diseases/Adulterated N/A *
12/12/2005 Morrell Farm [ARCHIVED] New York District Office Illegal Drug Residue N/A *
12/09/2005 Milk Flow Dairy [ARCHIVED] Denver District Office Illegal Drug Residue /Adulterated N/A *
12/09/2005 MCT Medical Products [ARCHIVED] Dallas District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
12/08/2005 Michael Mumbulo [ARCHIVED] New York District Office Illegal Drug Residue N/A *
12/07/2005 American Eagle/Executive Airlines, Inc. [ARCHIVED] San Juan District Office CGMP for Foods/Adulterated N/A *
12/07/2005 LifeScan, Inc. [ARCHIVED] San Francisco District Office CGMP requirements for the Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded N/A *
12/06/2005 WaJa Farms, Inc [ARCHIVED] New York District Office Illegal Drug Residue N/A *
12/05/2005 Two Brothers Seafood, Inc. [ARCHIVED] San Juan District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
12/05/2005 Pedro Barba & Sons Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
12/05/2005 IIT Research Institute [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
12/05/2005 Carrington Laboratories, Inc [ARCHIVED] Dallas District Office Insanitary Conditions/Adulterated/Misbranded N/A *
12/02/2005 Fabulous Fish Co. [ARCHIVED] Kansas City District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
12/02/2005 Restorative Products, Inc. [ARCHIVED] Florida District Office Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded N/A *
12/02/2005 Rite-Dent Manufacturing Corp. [ARCHIVED] Florida District Office Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded N/A *
12/01/2005 Samson Medical Technologies, Inc. [ARCHIVED] New Jersey District Office Labeling/New Drug/Misbranded N/A *
12/01/2005 Life Enhancement Products, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Food Additive Misbranded N/A *
12/01/2005 Yu I Hsiang U.S.A. corp [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
11/30/2005 Healthworks 2000 [ARCHIVED] Dallas District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/30/2005 YSIS, Incorporated [ARCHIVED] Cincinnati District Office Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded N/A *
11/30/2005 Iceland Health, Inc [ARCHIVED] Kansas City District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/30/2005 Vitacost.com [ARCHIVED] Florida District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/29/2005 BODeSTORE.com [ARCHIVED] New Jersey District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/29/2005 Chozyn, LLC [ARCHIVED] New Jersey District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/28/2005 Sacred Mountain Management Inc [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/28/2005 Spectrum Chemicals & Laboratory Products, Inc [ARCHIVED] New Jersey District Office Active Pharmaceutical Ingredients/Misbranded N/A *
11/23/2005 PolyCil Health Inc [ARCHIVED] Los Angeles District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/23/2005 PRB Pharmaceuticals [ARCHIVED] Los Angeles District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
11/23/2005 The Electrode Store, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
11/22/2005 G&S Instrument Company [ARCHIVED] Dallas District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
11/22/2005 NativeRemedies.com [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims False & Misleading/Misbranded N/A *
11/22/2005 Milbank Mills Inc [ARCHIVED] Kansas City District Office CGMP for Medicated Feeds/Adulterated N/A *
11/22/2005 Kramer Laboratories Inc. [ARCHIVED] Florida District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *

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