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U.S. Department of Health and Human Services

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 02, 2005 Ovation Pharmaceuticals, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/False & Misleading/Misbranded N/A *
June 01, 2005 Chan Ta Seafood [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
May 31, 2005 Bioteque America, Inc. [ARCHIVED] Philadelphia District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
May 27, 2005 Lydall, Inc. [ARCHIVED] Atlanta District Office CGMP/Adulterated N/A *
May 26, 2005 Constantine, Neil T Ph.D [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
May 26, 2005 C & M Oxyfill, LLC [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
May 26, 2005 P.&O. Cold Logistics [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
May 25, 2005 Biolmagene, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Approved Premarket Application/Adulterated N/A *
May 25, 2005 Apollo Export Warehouse, Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
May 24, 2005 Paul Meserve Distributor [ARCHIVED] New England District Office Food Labeling/Misbranded N/A *
May 24, 2005 Pascal Company, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
May 24, 2005 Seafarers Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
May 23, 2005 Telex Communications, Inc. [ARCHIVED] Kansas City District Office Quality System Regulation/Medical Device Reporting Regulation/Misbranded/Adulerated N/A *
May 19, 2005 Great & Best Co., Inc. [ARCHIVED] New Orleans District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
May 19, 2005 Spectronics Corporation [ARCHIVED] New York District Office Quality System Regulation for Medical Devices/Adulterated N/A *
May 18, 2005 Nucura Pharmaceuticals, Inc. [ARCHIVED] Los Angeles District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
May 18, 2005 Boston Scientific Corporation [ARCHIVED] New England District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
May 17, 2005 Pro*Act Specialties [ARCHIVED] Florida District Office Seafood HACCP N/A *
May 17, 2005 Aunt Lizzie's Cheese Straws, Inc [ARCHIVED] New Orleans District Office Food Labeling/Misbranded N/A *
May 17, 2005 Netuno USA, Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *



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ICECI Warning Letters

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