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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
April 27, 2005 Inoveon Corporation Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
April 27, 2005 PIE Medical International, Inc. Atlanta District Office Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded N/A *
April 27, 2005 Barney's Weir Cove Bakery Baltimore District Office Food Labeling Regulation N/A *
April 27, 2005 Wilbur Ellis Company Denver District Office CGMP/Adulterated N/A *
April 27, 2005 Gulf Marine & Industrial Supplies, Inc. New Orleans District Office Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
April 26, 2005 Summerland Seafood, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
April 26, 2005 Mitchell Farms Atlanta District Office Illegal Drug Residue /Adulterated N/A *
April 26, 2005 Digicare Biomedical Technology, Inc. Florida District Office Quality System Reguation/Adulterated N/A *
April 25, 2005 Deli To Go, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
April 22, 2005 ZooScape.com Center for Biologics Evaluation and Research Promotional Claims/False & Misleading/Misbranded N/A *
April 20, 2005 Field Roast Grain Company Seattle District Office Food Labeling/False & Misleading/Claims Misbranded N/A *
April 19, 2005 Yarbrough Produce Company New Orleans District Office Food Labeling/Misbranded N/A *
April 18, 2005 Great American Products, Inc Florida District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded N/A *
April 18, 2005 Convatec New Jersey District Office Quality System Regulation/Adulterated N/A *
April 18, 2005 Physician's Choice Inc. Florida District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded N/A *
April 18, 2005 Jowdy Industries, Inc Florida District Office Seafood HACCP/Adulterated N/A *
April 15, 2005 Pacific Rim Seafood San Francisco District Office Seafood HACCP/Adulterated N/A *
April 15, 2005 Alcon Laboratories, Inc. Florida District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
April 15, 2005 Bar-B-R Farm New York District Office Illegal Drug Residue N/A *
April 15, 2005 Andre Oran Leger, Inc. Chez Francois Seafood New Orleans District Office Seafood HACCP 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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