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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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
October 26, 2007 PlasmaCare, Inc. [ARCHIVED] Cincinnati District Office CFR Deviations N/A *
October 26, 2007 Chaganti, Surendra, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
October 26, 2007 Rapoport, Alan, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
October 23, 2007 Dan Dee Dairy, LLC [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
October 23, 2007 Sanofi-Aventis U.S. LLC [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
October 23, 2007 Del Oro Dairy [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
October 22, 2007 Heartland Products, Inc. [ARCHIVED] Minneapolis District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
October 18, 2007 Unipower Corporation [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 17, 2007 Calco Sprouts, Inc. [ARCHIVED] Minneapolis District Office CGMP Regulation For Food/Adulterated N/A *
October 17, 2007 Bradley Pacific Aviation, Inc. [ARCHIVED] San Francisco District Office CFR Deviations N/A *
October 17, 2007 coLigne AG [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
October 16, 2007 Moreno Valley Dairy [ARCHIVED] Los Angeles District Office Illegal Drug Residue N/A *
October 16, 2007 Fresh Made Incorporated [ARCHIVED] Philadelphia District Office Food Labeling/Cheese products/Misbranded N/A *
October 16, 2007 Health MarketPlace.com [ARCHIVED] Baltimore District Office Labeling Claims N/A *
October 16, 2007 Ally K. Enterprise Corporation [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
October 16, 2007 Health Freedom Nutrition, LLC [ARCHIVED] San Francisco District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
October 15, 2007 Biotivia America [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling Claims N/A *
October 15, 2007 Veldhuis North Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
October 12, 2007 Olympic Medical Corporation [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 12, 2007 Jen-On Herbal Science International Inc [ARCHIVED] Los Angeles District Office Dietary Supplement/Labeling False and Misleading/Misbranded N/A *
October 12, 2007 Pagano's Inc. [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 11, 2007 EXACT Sciences Corporation [ARCHIVED] Center for Devices and Radiological Health Device/Adulterated N/A *
October 10, 2007 J & M Dairy [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
October 10, 2007 Fuji Food Products Inc [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
October 10, 2007 Lipari Food Products, Inc [ARCHIVED] Detroit District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 10, 2007 Arrow International, Inc. [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 09, 2007 Fullmer Cattle Company New Mexico LLC [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
October 09, 2007 4 D Cattle [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
October 05, 2007 EM Probe Inc. [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 05, 2007 Tri Mast Dairy [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
October 04, 2007 Washington Hospital Center [ARCHIVED] Baltimore District Office CGMP for Blood & Blood Components/Adulterated N/A *
October 03, 2007 Deep Blue Seafood [ARCHIVED] Denver District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 02, 2007 iScreen, LLC [ARCHIVED] New Orleans District Office CGMP/Quality System/Adulterated N/A *
October 02, 2007 Dialysis Dimensions Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 01, 2007 Medtronic Incorporated [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
October 01, 2007 Bradford, Michael, MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
October 01, 2007 Warsaw Orthopedic Inc [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 28, 2007 Cameron-Miller, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
September 28, 2007 Med-South Pharmacy Inc. [ARCHIVED] New Orleans District Office Pharmacy Compounding/New Drug/Adulterated/Misbranded N/A *
September 28, 2007 GE Infrastructure, Water & Process Technologies [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 28, 2007 Healthway Home Products, Inc [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 28, 2007 Efficas, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling & Promotional Claims N/A *
September 26, 2007 Duane Oxendale Detroit District Office Illegal Drug Residue N/A *
September 26, 2007 Golden View LP Los Angeles District Office Illegal Drug Residue N/A *
September 25, 2007 East Coast Meat & Seafood [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 25, 2007 Aquamar Fisheries, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 24, 2007 Alternative Health Approaches [ARCHIVED] Los Angeles District Office Drug Labeling/Promotional Claims/Misbranded N/A *
September 24, 2007 Chiu Technical Corp. [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 24, 2007 SCM True Air Technologies LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 21, 2007 Imperial Food Services, Inc. [ARCHIVED] Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *

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ICECI Warning Letters

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Food and Drug Administration

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