2007 Warning Letters

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Warning Letters for 2007

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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

 

Posted on February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
January 24, 2007	Farmers Livestock Market of Glasgow	Cincinnati District Office	Adulterated Food	N/A *
January 24, 2007	Good Flow Juice Company	Dallas District Office	Juice/HACCP/Adulterated	N/A *
January 23, 2007	Avlon Industries	Center for Drug Evaluation and Research	Sponsor/Investigator	N/A *
January 19, 2007	Avlon Industries	Center for Drug Evaluation and Research	Sponsor-Investigator	N/A *
January 19, 2007	Levitronix LLC	Center for Devices and Radiological Health	CGMP/QSR/Medical Device Reporting/Adulterated	N/A *
January 19, 2007	DreamWest Innovations, LLC	Dallas District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
January 16, 2007	Gynetics Medical Products NV	Center for Devices and Radiological Health	CGMP for Medical Devices/QS/Adulterated	N/A *
January 16, 2007	Power Products, Inc.-Splintek	Center for Devices and Radiological Health	Premarket Approval/Adulterated	N/A *
January 16, 2007	Vander Werff Rigg Dairy	San Francisco District Office	Illegal Drug Residue	N/A *
January 16, 2007	Kim, Lawrence S. , M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
January 16, 2007	Alternative Health & Herbs Remedies	Seattle District Office	New Drugs	N/A *
January 12, 2007	Kagan, Richard J., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
January 11, 2007	Omnicare, Inc.	Cincinnati District Office	Current Good Manufacturing Practice/Adulterated	N/A *
January 11, 2007	Doody Farms, LLC	New York District Office	Drug Residue in Edible Tissue/Adulterated	N/A *
January 11, 2007	Encore Medical, LP	Dallas District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
January 11, 2007	Western Fish Company, Inc.	Los Angeles District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
January 10, 2007	Liberty Dairy LLC	Seattle District Office	Illegal Drug Residue	N/A *
January 09, 2007	DP Manufacture Corporation	Florida District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
January 09, 2007	Advanced Reproductive Laboratory	Dallas District Office	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products	N/A *
January 08, 2007	O'Shaughnessy, Charles D, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
January 08, 2007	Hardy Diagnostic	Center for Devices and Radiological Health	Lacks Premarket Approval Application/Adulterated/Misbranded	N/A *
January 08, 2007	Caribbean Ventures Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
January 08, 2007	Kalchem International, Inc.	Center for Drug Evaluation and Research	New Drug	N/A *
January 05, 2007	Bell-More Laboratories, Inc.	Baltimore District Office	CGMP Deviations	N/A *
January 04, 2007	West Coast Pita and Food, Inc.	Seattle District Office	Insanitary Conditions/Food Storage Warehouse/Adulterated	N/A *
January 04, 2007	Winchester Bay Seafood, Inc.	Seattle District Office	Seafood HACCP/Adulterated	N/A *

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