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U.S. Department of Health and Human Services

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2007 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
09/21/2007 Ben J. Weaver New York District Office Illegal Drug Residue N/A *
09/20/2007 Toms, Matthew Baltimore District Office Illegal Drug Residue N/A *
09/19/2007 Zinnanti Surgical Design, LLC [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated N/A *
09/19/2007 Genzyme Corporation [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations N/A *
09/18/2007 Amato, Robert J., D.O. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
09/14/2007 Procter and Gamble [ARCHIVED] Cincinnati District Office Labeling/OTC Drugs N/A *
09/11/2007 Tembec, Inc. [ARCHIVED] Cincinnati District Office Food Additive/Adulterated/Misbranded N/A *
09/11/2007 Universal Enterprises, Inc. [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation/Control of Communicable Disease N/A *
09/11/2007 American Nutrition, Inc [ARCHIVED] Denver District Office Animal Food/Misbranded/Labeling N/A *
09/10/2007 Murvest, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
09/07/2007 North Coast Medical Inc. [ARCHIVED] San Francisco District Office CGMP/QSR/Medical Devices/Adulterated N/A *
09/06/2007 Danmar Product, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
09/06/2007 Kunshan Chemical and Pharmaceutical Co., Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
09/04/2007 Sorenson Medical, Inc. [ARCHIVED] Denver District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
09/04/2007 Tobler, William D., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
08/30/2007 Millner Trading Company, Inc. [ARCHIVED] Philadelphia District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded N/A *
08/30/2007 Boston Scientific Cardiovascular [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
08/30/2007 Melanocorp, Inc. [ARCHIVED] New Orleans District Office Drug/Lacks Approved Application N/A *
08/29/2007 Ochsner Clinic Foundation [ARCHIVED] New Orleans District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
08/29/2007 Oberlander Baking Co. [ARCHIVED] Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded N/A *
08/29/2007 All Medicus Co. Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Devices/Adulterated N/A *
08/29/2007 Fish Busterz L.L.C [ARCHIVED] Florida District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
08/28/2007 Chris & Tracey Elbe Dairy Farm Minneapolis District Office Illegal Drug Residue N/A *
08/28/2007 Leiner Health Products, LLC [ARCHIVED] Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
08/27/2007 Sea Farms Incorporated [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
08/27/2007 Wheaton Beauty Supply [ARCHIVED] Baltimore District Office Device/Lacks Approved/Misbranded N/A *
08/23/2007 Potty MD, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
08/22/2007 F. H. G. Corporation [ARCHIVED] Florida District Office Promotional Claims/Misbranded N/A *
08/21/2007 Hyson USA Inc [ARCHIVED] Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
08/21/2007 Beef Northwest Feeders, LLC Seattle District Office Illegal Drug Residue N/A *
08/20/2007 Vigor Nutriceutical Healthcare, Inc. [ARCHIVED] Minneapolis District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
08/17/2007 American Mobile Medical Surgical Group Inc [ARCHIVED] New Jersey District Office Mammography Quality Standards Act N/A *
08/17/2007 Hidden Valley Mills [ARCHIVED] Los Angeles District Office Juice HACCP/Adulterated N/A *
08/17/2007 Hain Celestial Group, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated N/A *
08/16/2007 Blue Heron Bakery, Inc. [ARCHIVED] Seattle District Office False & Misleading Claims/Misbranded N/A *
08/15/2007 Spineology, Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
08/13/2007 World Sushi Express, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
08/10/2007 Mark Nolt Farm d/b/a Nature's Sunlight Farm [ARCHIVED] Philadelphia District Office Interstate Commerce/Misbranded N/A *
08/10/2007 Belvin Seafood Corporation [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
08/09/2007 Arizona Dairy Company, LLP Los Angeles District Office Illegal Drug Residue N/A *
08/08/2007 Novis PR dba Kramer-Novis [ARCHIVED] San Juan District Office OTC Drug Products/Dietary Supplements/Misbranded N/A *
08/08/2007 Swanson Health Products, Inc. [ARCHIVED] Minneapolis District Office Dietary Supplements N/A *
08/07/2007 Sunburst Biorganics [ARCHIVED] New York District Office Dietary Supplements N/A *
08/02/2007 Cook's Seafood Company [ARCHIVED] Baltimore District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
08/01/2007 Sunoptic Technologies, LLC [ARCHIVED] Florida District Office CGMP for Medical Devices/Adulterated N/A *
07/31/2007 Genaros Seafood, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated/Misbranded N/A *
07/31/2007 Riverfront Fish Market [ARCHIVED] Dallas District Office Seafood HACCP N/A *
07/31/2007 Bay Valley Foods, LLC [ARCHIVED] Philadelphia District Office Acidified Foods/Adulterated N/A *
07/30/2007 Pulse Biomedical, Inc. [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/30/2007 GMI European Food Distributors Inc. [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *

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ICECI Warning Letters

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