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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2007 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters for 2007

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

 

* 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
January 16, 2007 Kim, Lawrence S. , M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
January 16, 2007 Alternative Health & Herbs Remedies [ARCHIVED] Seattle District Office New Drugs N/A *
January 12, 2007 Kagan, Richard J., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
January 11, 2007 Omnicare, Inc. [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice/Adulterated N/A *
January 11, 2007 Encore Medical, LP [ARCHIVED] Dallas District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
January 11, 2007 Western Fish Company, Inc. [ARCHIVED] Los Angeles District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
January 11, 2007 Doody Farms, LLC [ARCHIVED] New York District Office Drug Residue in Edible Tissue/Adulterated N/A *
January 10, 2007 Liberty Dairy LLC [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
January 09, 2007 DP Manufacture Corporation [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 09, 2007 Advanced Reproductive Laboratory [ARCHIVED] Dallas District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
January 08, 2007 Caribbean Ventures Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
January 08, 2007 Hardy Diagnostic [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
January 08, 2007 Kalchem International, Inc. [ARCHIVED] Center for Drug Evaluation and Research New Drug N/A *
January 08, 2007 O'Shaughnessy, Charles D, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
January 05, 2007 Bell-More Laboratories, Inc. [ARCHIVED] Baltimore District Office CGMP Deviations N/A *
January 04, 2007 Winchester Bay Seafood, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
January 04, 2007 West Coast Pita and Food, Inc. [ARCHIVED] Seattle District Office Insanitary Conditions/Food Storage Warehouse/Adulterated N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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