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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2005 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2005

 

* 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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 09, 2005 Lifeway Foods, Inc. Philadelphia District Office Seafood HACCP/Misbranded N/A *
August 08, 2005 E.A. Sween Company Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
August 04, 2005 I.V. Flush, LLC Dallas District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
August 03, 2005 Arrow International, Inc. Dallas District Office Current Good Manufacturing Practice (CGMP) Adulterated/Misbranded N/A *
August 02, 2005 Keeler's Medical Supply, Inc. Seattle District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
August 02, 2005 Mike's Seafood New Orleans District Office Seafood HACCP/Adulterated N/A *
August 01, 2005 Huntsville Hospital Institutional Review Committee Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
August 01, 2005 Boston Scientific Corporation New York District Office Quality System Regulation/Adulterated N/A *
August 01, 2005 Marlen Martin Farm Detroit District Office Illegal Drug Residue/Adulterated N/A *
July 29, 2005 Access Genetics Center for Devices and Radiological Health Lacks Premarket Notification Approval/Adulterated/Misbranded N/A *
July 29, 2005 BioMerieux, Inc. Office of Enforcement CGMP/IVR Manufacturing N/A *
July 29, 2005 ElderTech Solutions, LLC Seattle District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
July 29, 2005 Halstead Springs, Inc. New Orleans District Office CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated N/A *
July 27, 2005 Superior Rehab Technology, Inc. Dallas District Office Current Good Manufacturing Practice/Adulterated/Misbranded N/A *
July 27, 2005 Beam of Light Technologies, Inc. Center for Devices and Radiological Health Laser Product Performance Standard/Labeling N/A *
July 26, 2005 Maria Medeiros Dairy San Francisco District Office Illegal Drug Residue /Adulterated N/A *
July 25, 2005 Morris Veterinary Center, PSC Minneapolis District Office Illegal Drug Residue N/A *
July 25, 2005 Le Gourmet Lorrain, Inc. Baltimore District Office Food Labeling/Misbranded N/A *
July 22, 2005 Merck & Company, Inc. Office of Enforcement Biologics License/Adulterated N/A *
July 21, 2005 MJM International Corporation Dallas District Office CGMP/QSR/Lacks Premarket Approval Application/Medical Device Reporting Regulation N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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