2008 Warning Letters

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Warning Letters issued in 2008

 

* 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 30, 2008	Dongkuk Techco Rubber Ind. Sdn Bhd	Center for Devices and Radiological Health	CGMP/QSR/Adulterated	N/A *
December 30, 2008	Kidron Auction Inc.	Cincinnati District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
December 24, 2008	Aunt Kitty's Foods, Inc.	New Jersey District Office	Food Labeling Misbranded	N/A *
December 24, 2008	Stoney Acres Calves	Detroit District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
December 22, 2008	Columbia Presbyterian Medical Center	New York District Office	Deviation/Adulterated	N/A *
December 22, 2008	Newman's Own Organics	Center for Food Safety and Applied Nutrition		N/A *
December 22, 2008	Troyer, Todd	Cincinnati District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
December 22, 2008	Newman's Own Organics	Center for Food Safety and Applied Nutrition	Federal Food, Drug and Cosmetic Act/Misbranded	N/A *
December 22, 2008	I-Flow Corporation	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
December 16, 2008	Civic Center Pharmacy	Los Angeles District Office	New Drug, Unapproved	N/A *
December 15, 2008	Craig General Hospital	Dallas District Office	Deviation from Good Manufacturing Practice	N/A *
December 10, 2008	Coca-Cola Company (The)	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/Adulterated/Misbranded	N/A *
December 10, 2008	Virbac Inc.	Kansas City District Office	CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded	N/A *
December 10, 2008	Savec Health Systems	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
December 08, 2008	RGI Medical Manufacturing, Inc.	Florida District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
December 05, 2008	Douglas Bennett Farm	New England District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
December 05, 2008	Pneumex, Incorporated	Seattle District Office	Premarket Approval/Misbranded/Adulterated	N/A *
December 04, 2008	Carib Supply of St. Croix, Inc.	San Juan District Office	CGMP Manufacture, Processing, Packing or Holding of Human Drugs/Adulterated	N/A *
December 04, 2008	Haemonetics Corporation	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
December 03, 2008	Kids Company Ltd Yugengaisha Kids	Center for Devices and Radiological Health	Device/Lacks Approved Premarket Application/Adulterated/Misbranded	N/A *
December 01, 2008	Perich, Larry M	Baltimore District Office	Clinical Investigator	N/A *
December 01, 2008	Vital Signs, Inc.	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
November 26, 2008	B & C Calves/Livestock	Philadelphia District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
November 25, 2008	Lett Us One Corporation	San Juan District Office	CGMP Manufacturing, Packing, or Holding Human Food/Adulterated	N/A *
November 24, 2008	PDS Manufacturing, Inc.	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 24, 2008	Gonzalez Dairy, LLC	Denver District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
November 24, 2008	Actelion Pharmaceuticals US, Inc.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
November 20, 2008	Contract Medical Manufacturing	New England District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 19, 2008	Goosefoot Acres, Inc.	Cincinnati District Office	Labeling/False & Misleading Claims/New Drug/Misbranded	N/A *
November 19, 2008	Bernhard's Bakery, Inc.	Cincinnati District Office	CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated	N/A *
November 18, 2008	Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes	Los Angeles District Office	Human Cells, Tissues & Cellular Products	N/A *
November 18, 2008	Surgical Implant Generation Network	Seattle District Office	CGMP for Medical Devices/QS/Adulterated	N/A *
November 18, 2008	RHG & Company, Inc., dba Vital Nutrients	New England District Office	New Drug/Labeling/False & Misleading Claims/Misbranded	N/A *
November 17, 2008	Dabruzzi's Italian Foods, Inc.	Minneapolis District Office	Food Labeling/False & Misleading/Misbranded	N/A *
November 14, 2008	Shinogi USA, Inc.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
November 14, 2008	Eagle Parts and Products	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 13, 2008	G.N.Y. Filet Fish Co., Inc.	New York District Office	Seafood HACCP/GMP for Foods/Adulterated	N/A *
November 13, 2008	Saudek, Christopher D. MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
November 13, 2008	Lam, Fred M.D.	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *
November 13, 2008	American Association of Acupuncture and Bio-Energetic Medicine	Center for Devices and Radiological Health	Institutional Review Board	N/A *
November 13, 2008	Saudek, Christopher D., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
November 13, 2008	Rezai, Ali R, M.D	Center for Devices and Radiological Health	Clinical Investigator	N/A *
November 12, 2008	John Mellott Farm	Philadelphia District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
November 12, 2008	Steven's Pharmacy	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims	N/A *
November 12, 2008	John M. Mellott Farm	Philadelphia District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
November 07, 2008	Hai Soon Leong Sdn Bhd	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
November 04, 2008	Innovative Neurotronic, Inc.	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 03, 2008	Spacelabs Healthcare Incorporated	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
October 31, 2008	Caraco Pharmaceutical Laboratories, Ltd	Detroit District Office	CGMP Deviations	N/A *
October 31, 2008	Deltex Pharmaceuticals Inc	Dallas District Office	CGMP/Otc Drug Products/Adulterated	N/A *