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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2005 Warning Letters

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Tobacco Retailer Warning Letters

 

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 27, 2005 Jones, Spencer B. M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
October 26, 2005 Balsiger Greiner Rohweder Dairy, LLP [ARCHIVED] Minneapolis District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
October 25, 2005 Woodward Laboratories [ARCHIVED] Los Angeles District Office Labeling/New Drug/Misbranded N/A *
October 24, 2005 Primary Care Solutions, Inc. [ARCHIVED] Florida District Office Quality System Regulation/Medical Device Reporting N/A *
October 20, 2005 Diversified Manufacturing Corporation [ARCHIVED] Minneapolis District Office CGMP for Finished Pharmaceutical N/A *
October 19, 2005 American I.V. Products, Inc. [ARCHIVED] Baltimore District Office CGMP Requirement of the Quality System Regulation for Medical Device N/A *
October 19, 2005 Archer Daniels Midland Company [ARCHIVED] Kansas City District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
October 19, 2005 Bio-Germ Protection, LLC [ARCHIVED] Dallas District Office Labeling / New Drug Application N/A *
October 18, 2005 Foods Galore Inc [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated N/A *
October 18, 2005 Klutts, Walter J. [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
October 18, 2005 NeuroResearch, Inc [ARCHIVED] Minneapolis District Office Labeling/New Drug/Misbranded N/A *
October 18, 2005 Precision Converters, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
October 17, 2005 Lelanau Fruit Company [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Amon Orchards [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Rowley and Hawkins Fruit Farm [ARCHIVED] Seattle District Office Labeling and Promotional Violations N/A *
October 17, 2005 Sunrise Dried Fruit Co. [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Eden Foods, Inc. [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Flavonoid Sciences [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Rowley's South Ridge Farms, Inc. [ARCHIVED] Denver District Office Labeling/New Drug/False & Misleading Claims/Misbranded N/A *
October 17, 2005 Heritage Products International [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Neptune Smoked Fish Company LLC [ARCHIVED] Minneapolis District Office CGMP for Foods/Seafood HACCP N/A *
October 17, 2005 Cherry Republic [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Overlake Foods Corporation [ARCHIVED] Seattle District Office Labeling and Promotional Violations N/A *
October 17, 2005 Payson Fruit Growers, Inc. [ARCHIVED] Denver District Office Labeling and Promotional Violations N/A *
October 17, 2005 J.R. Simplot Company [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulations for Medicated Feeds/Adulterated N/A *
October 17, 2005 Orchard's Harvest [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Brownwood Acres Foods, Inc. [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Cherry Lands Best [ARCHIVED] Minneapolis District Office Labeling and Promotional Violations N/A *
October 17, 2005 TPG Enterprises, Inc. [ARCHIVED] Seattle District Office Labeling and Promotional Violations N/A *
October 17, 2005 Seaquist Orchards [ARCHIVED] Minneapolis District Office Labeling and Promotional Violations N/A *
October 17, 2005 Country Ovens, Ltd. [ARCHIVED] Minneapolis District Office Labeling and Promotional Violations N/A *
October 17, 2005 Royal Ridge Fruit & Cold Storage [ARCHIVED] Seattle District Office Labeling and Promotional Violations N/A *
October 17, 2005 Skyview Orchards [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Cherry Rx [ARCHIVED] Minneapolis District Office Labeling and Promotional Violations N/A *
October 17, 2005 Friske Orchards [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Obstbaum Orchards [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Willharvdoit Corporation [ARCHIVED] Minneapolis District Office CGMP for Foods/Seafood HACCP N/A *
October 17, 2005 H & W Farms [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 The Country Mill, LLC [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 King Orchards [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Chukar Cherry Company [ARCHIVED] Seattle District Office Labeling and Promotional Violations N/A *
October 17, 2005 Ram Precision Industries, Inc. [ARCHIVED] Cincinnati District Office Quality System Regulation/Adultered N/A *
October 17, 2005 Traverse Bay Farms [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 17, 2005 Coloma Frozen Foods [ARCHIVED] Detroit District Office Labeling and Promotional Violations N/A *
October 14, 2005 BioHarmonics Research and Consulting [ARCHIVED] Atlanta District Office Lacks Premarket Approval Application Misbranded N/A *
October 14, 2005 Weese-Mayer, Debra E., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
October 13, 2005 Professional Hair Institute, Inc. [ARCHIVED] Baltimore District Office Lacks Approved New Drug Application/Misbranded N/A *
October 12, 2005 Niitikaya USA Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
October 12, 2005 B. Braun Medical Inc [ARCHIVED] New Jersey District Office Quality System Regulation for Medical Devices/Adulterated N/A *
October 11, 2005 Rowen, Sheri L., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *

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ICECI Warning Letters

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