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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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2007 Warning Letters

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Warning Letters for 2007

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 29, 2007 All Medicus Co. Ltd Center for Devices and Radiological Health CGMP for Medical Devices/Adulterated N/A *
August 29, 2007 Ochsner Clinic Foundation New Orleans District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
August 28, 2007 Leiner Health Products, LLC Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
August 28, 2007 Chris & Tracey Elbe Dairy Farm Minneapolis District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
August 27, 2007 Wheaton Beauty Supply Baltimore District Office Device/Lacks Approved/Misbranded N/A *
August 27, 2007 Sea Farms Incorporated Baltimore District Office Seafood HACCP/Adulterated N/A *
August 23, 2007 Potty MD, LLC New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 22, 2007 F. H. G. Corporation Florida District Office Promotional Claims/Misbranded N/A *
August 21, 2007 Beef Northwest Feeders, LLC Seattle District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
August 21, 2007 Hyson USA Inc Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 20, 2007 Vigor Nutriceutical Healthcare, Inc. Minneapolis District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
August 17, 2007 Hidden Valley Mills Los Angeles District Office Juice HACCP/Adulterated N/A *
August 17, 2007 Hain Celestial Group, Inc. Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated N/A *
August 17, 2007 American Mobile Medical Surgical Group Inc New Jersey District Office Mammography Quality Standards Act N/A *
August 16, 2007 Blue Heron Bakery, Inc. Seattle District Office False & Misleading Claims/Misbranded N/A *
August 15, 2007 Spineology, Inc. Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
August 13, 2007 World Sushi Express, Inc. Los Angeles District Office Seafood HACCP/Adulterated N/A *
August 10, 2007 Belvin Seafood Corporation Baltimore District Office Seafood HACCP/Adulterated N/A *
August 10, 2007 Mark Nolt Farm d/b/a Nature's Sunlight Farm Philadelphia District Office Interstate Commerce/Misbranded N/A *
August 09, 2007 Arizona Dairy Company, LLP Los Angeles District Office Animal Sale for Slaughter as Food/Adulterated N/A *



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ICECI Warning Letters

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