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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 09, 2005 MCT Medical Products [ARCHIVED] Dallas District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
December 08, 2005 Michael Mumbulo [ARCHIVED] New York District Office Illegal Drug Residue N/A *
December 07, 2005 American Eagle/Executive Airlines, Inc. [ARCHIVED] San Juan District Office CGMP for Foods/Adulterated N/A *
December 07, 2005 LifeScan, Inc. [ARCHIVED] San Francisco District Office CGMP requirements for the Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded N/A *
December 06, 2005 WaJa Farms, Inc [ARCHIVED] New York District Office Illegal Drug Residue N/A *
December 05, 2005 Two Brothers Seafood, Inc. [ARCHIVED] San Juan District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
December 05, 2005 Pedro Barba & Sons Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
December 05, 2005 IIT Research Institute [ARCHIVED] Center for Drug Evaluation and Research GLP for non-clincal laboratory studies N/A *
December 05, 2005 Carrington Laboratories, Inc [ARCHIVED] Dallas District Office Insanitary Conditions/Adulterated/Misbranded N/A *
December 02, 2005 Fabulous Fish Co. [ARCHIVED] Kansas City District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
December 02, 2005 Restorative Products, Inc. [ARCHIVED] Florida District Office Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded N/A *
December 02, 2005 Rite-Dent Manufacturing Corp. [ARCHIVED] Florida District Office Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded N/A *
December 01, 2005 Samson Medical Technologies, Inc. [ARCHIVED] New Jersey District Office Labeling/New Drug/Misbranded N/A *
December 01, 2005 Life Enhancement Products, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Food Additive Misbranded N/A *
December 01, 2005 Yu I Hsiang U.S.A. corp [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
November 30, 2005 Healthworks 2000 [ARCHIVED] Dallas District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
November 30, 2005 YSIS, Incorporated [ARCHIVED] Cincinnati District Office Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded N/A *
November 30, 2005 Iceland Health, Inc [ARCHIVED] Kansas City District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
November 30, 2005 Vitacost.com [ARCHIVED] Florida District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
November 29, 2005 BODeSTORE.com [ARCHIVED] New Jersey District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *



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ICECI Warning Letters

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