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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 23, 2005 Estill Medical Technologies, Inc. Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 23, 2005 Gottlieb, Michael S., M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
August 22, 2005 Universal Nutraceuticals, Inc. Baltimore District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
August 22, 2005 Tyco Healthcare Group Center for Devices and Radiological Health Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation N/A *
August 19, 2005 Furst McNess Company Cincinnati District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
August 19, 2005 Oklahoma Blood Institute Dallas District Office Current Good Manufacturing Practices for Blood & Components/Adulterated N/A *
August 18, 2005 Enzymology Research Center, Inc. Minneapolis District Office Labeling/Promotional Claims False & Misleading/Misbranded N/A *
August 18, 2005 Can-X Products, Inc. San Francisco District Office Dietary Supplement Labeling Regulations/Misbranded N/A *
August 18, 2005 UltraFoods, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
August 18, 2005 Neukon Groves, Inc. Florida District Office Juice HACCP N/A *
August 18, 2005 Martin-Vue Farms Detroit District Office Illegal Tissue Residues/Adulterated N/A *
August 16, 2005 Chiyoda Sushi New York Inc New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
August 16, 2005 Similasan AG Center for Drug Evaluation and Research Cuurent Good Manufacturing Practice/Adulterated/Misbranded N/A *
August 16, 2005 Chiyoda Sushi New York, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
August 15, 2005 Lifestream Medical Corporation Center for Devices and Radiological Health Sponsor Obligations N/A *
August 11, 2005 AM2 PAT, Inc Atlanta District Office Quality System Regulation/Adulterated N/A *
August 11, 2005 Haidylena for Advanced Medical Industries Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 10, 2005 Boston Scientific Corporation New England District Office Current Good Manufacturing Practice (CGMP) requirements for medical devices/adulterated N/A *
August 10, 2005 G & G Dairy Seattle District Office Illegal Drug Residue /Adulterated N/A *
August 10, 2005 Hispamer Distributors, Inc. Florida District Office Seafood HACCP/Adulterated N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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Rockville, MD 20857
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