2005 Warning Letters

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Warning Letters issued in 2005

 

* 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
November 22, 2005	G&S Instrument Company	Dallas District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
November 21, 2005	Medina & Medina, Inc	San Juan District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
November 21, 2005	Revival Animal Health, Inc.	Kansas City District Office	Promotional Claims False & Misleading/Adulterated/Misbranded	N/A *
November 18, 2005	Normed Medizin-Technik GmbH	Center for Devices and Radiological Health	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
November 16, 2005	LA Fish Company	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
November 16, 2005	Chun Cheng USA Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
November 16, 2005	Scientific Laboratories, Inc.	Baltimore District Office	CGMP for Finished Pharmaceuticals/Adulterated	N/A *
November 16, 2005	Globalemed, LLC	Baltimore District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
November 16, 2005	Four Brothers Dairy, Incorporated	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
November 16, 2005	Majestic International Spice	Los Angeles District Office	Import/Lacks May Proceed or Release Notice	N/A *
November 15, 2005	Rainbow Acresa	New York District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
November 15, 2005	De Groot Dairy, L.L.C.	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
November 14, 2005	Genetic Testing Institute, Incorporated	Minneapolis District Office	Lacks Premarket Approval Application Adulterated	N/A *
November 14, 2005	Memorial Blood Centers	Minneapolis District Office	CGMP/Finished Pharmaceuticals/Adulterated	N/A *
November 14, 2005	De Boer Dairy	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
November 10, 2005	Bobby Chez, Inc.	New Jersey District Office	Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
November 10, 2005	Bartush-Schnitzius Foods Co.	Dallas District Office	CGMP for Foods/HACCP	N/A *
November 10, 2005	Custom Feed Services Corporation	Kansas City District Office	CGMP/Medicated Feeds/Adulterated	N/A *
November 10, 2005	Creative Clinical Concepts, Inc.	Center for Devices and Radiological Health	Lacks Premarket Approval Application Misbranded	N/A *
November 09, 2005	The Way Up	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Sweet Dreems, Inc.	Cincinnati District Office	Quality System Reguation/Adulterated	N/A *
November 09, 2005	CHS International Research Ltd.	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Wilderness Family Naturals	Minneapolis District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Zlabs, LLC	Center for Drug Evaluation and Research	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Suzanne's Natural Foods	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	HMS Crown, Inc	Center for Drug Evaluation and Research	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Healthworks 2000	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	ESBA Laboratories, Inc.	Florida District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	One Life USA	Center for Drug Evaluation and Research	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Heba Laboratories, LLC	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	J Navigator, Inc.	Florida District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	All Natural Pain Relief, Inc.	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	BuyInnovation.com	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Nutriteam, Inc.	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Tip Top Vitamins	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Healthy Days, Inc.	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Greatest Herbs on Earth	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Herbal Fields Supplements	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	ComCore 21 Corporation	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 03, 2005	SLI Dairy	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
November 03, 2005	OASIS Medical, Inc.	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
November 02, 2005	Morgan Mill Trout Farm	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
November 02, 2005	Viet-Link Co.	New England District Office	Seafood HACCP/GMP Requirements for Foods	N/A *
November 02, 2005	Ana-Tech	Minneapolis District Office	Labeling/New Animal Drug/New Drug/Dietary Supplements/Misbranded	N/A *
November 01, 2005	Prime Deli Corporation	Dallas District Office	CGMP Regulation For Food/Adulterated	N/A *
November 01, 2005	GenTrac, Inc	Center for Biologics Evaluation and Research	Labeling/Promotional Claims False & Misleading/Misbranded	N/A *
November 01, 2005	Laomerica Seafood, Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
October 31, 2005	Quantum Skincare, Inc.	New Orleans District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
October 31, 2005	C & M Hilt Dairy	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
October 31, 2005	Vierstra & Son, Inc. dba Classic Dairy	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *

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