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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
October 17, 2005 Rowley's South Ridge Farms, Inc. Denver District Office Labeling/New Drug/False & Misleading Claims/Misbranded N/A *
October 17, 2005 Flavonoid Sciences Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Eden Foods, Inc. Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Sunrise Dried Fruit Co. Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Rowley and Hawkins Fruit Farm Seattle District Office Labeling and Promotional Violations N/A *
October 14, 2005 Weese-Mayer, Debra E., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
October 14, 2005 BioHarmonics Research and Consulting Atlanta District Office Lacks Premarket Approval Application Misbranded N/A *
October 13, 2005 Professional Hair Institute, Inc. Baltimore District Office Lacks Approved New Drug Application/Misbranded N/A *
October 12, 2005 B. Braun Medical Inc New Jersey District Office Quality System Regulation for Medical Devices/Adulterated N/A *
October 12, 2005 Niitikaya USA Inc. Los Angeles District Office Seafood HACCP/Adulterated N/A *
October 11, 2005 Buss, Merle R. Dallas District Office Illegal Drug Residue N/A *
October 11, 2005 Rowen, Sheri L., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
October 07, 2005 Roy and Malensky Seattle District Office Juice HACCP N/A *
October 07, 2005 Dexter Dairy Denver District Office Illegal Drug Residue /Adulterated N/A *
October 07, 2005 Mulingtapang, Reynaldo F. MD Center for Devices and Radiological Health Clinical Investigator N/A *
October 07, 2005 Fisher's Homestyle Salads Philadelphia District Office Seafood HACCP/Adulterated N/A *
October 06, 2005 Before and After Cosmetic LLC New Jersey District Office Labeling/New Drug/Misbranded N/A *
October 06, 2005 September Enterprises, Inc. Minneapolis District Office Seafood HACCP/Adulterated N/A *
October 05, 2005 Panbio, Inc. Baltimore District Office Lacks Premarket Approval Application/Misbranded N/A *
October 05, 2005 Penn Herb Co Ltd. Philadelphia District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded 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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