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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
July 01, 2005 Blake Street Manufacturing, LLC [ARCHIVED] Denver District Office Food Labeling Misbranded N/A *
June 30, 2005 Global Manufacturing & Engineering, LLC [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice/Adulterated N/A *
June 29, 2005 Con-Med Corporation [ARCHIVED] Florida District Office Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded N/A *
June 29, 2005 CrestLab Inc. [ARCHIVED] Detroit District Office Current Good Manufacturing Practice/Adulterated N/A *
June 28, 2005 Kabobs, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
June 28, 2005 Bimeda MTC Animal Health Inc. [ARCHIVED] Center for Veterinary Medicine Current Good Manufacturing Practice Regulation/Adulterated N/A *
June 28, 2005 MedTec Inc [ARCHIVED] Kansas City District Office QSR/Medical Devices/Adulterated N/A *
June 27, 2005 Homen Dairy Farms, LP [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
June 24, 2005 Greer Laboratories, Inc. [ARCHIVED] Office of Enforcement CGMP for Finished Pharmaceutical N/A *
June 24, 2005 Georgia Biomedical, Inc. [ARCHIVED] Atlanta District Office Quality System Reguation/Adulterated N/A *
June 23, 2005 Khoury, Michael MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
June 23, 2005 Lee Medical International, Inc. [ARCHIVED] New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
June 23, 2005 St. John Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
June 22, 2005 Customed, Inc. [ARCHIVED] San Juan District Office CGMP for Medical Devices/QS/Adulterated N/A *
June 22, 2005 Certified Natural Laboratories, Inc. [ARCHIVED] Kansas City District Office Dietary Supplements/Labeling/Misbranded N/A *
June 21, 2005 Custom Ultrasonics, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
June 21, 2005 MedImmune Vaccines, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
June 21, 2005 Lake Erie Medical and Surgical, Inc. [ARCHIVED] Detroit District Office Current Good Mfg Practice Regulation/Adulterated/Misbranded N/A *
June 20, 2005 Food With Care Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
June 17, 2005 Pragmatic Materials, Inc. [ARCHIVED] Cincinnati District Office Active Pharmaceutical Ingredient/Adulterated N/A *



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ICECI Warning Letters

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Food and Drug Administration

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