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
July 27, 2007	Traina, Steve M., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 27, 2007	Eury, Edward J., Jr.	Baltimore District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
July 26, 2007	Rogers Farm	New England District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
July 26, 2007	Eidam Diagnostics Corporation	Center for Devices and Radiological Health	Device Labeling/Quality System Regulation/Misbranded/Adulterated	N/A *
July 25, 2007	Pharmaceutical Laboratories and Consultants, Inc.	Chicago District Office	Current Good Manufacturing Practice/Adulterated	N/A *
July 24, 2007	Gebauer Company	Cincinnati District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
July 23, 2007	Miami Terminal Cold Storage, LLC	Florida District Office	Seafood HACCP/Adulterated	N/A *
July 18, 2007	Louisville APL Diagnostics, Inc.	Dallas District Office	Device/Adulterated	N/A *
July 17, 2007	Nanogen Point-of-Care Diagnostic Division	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
July 16, 2007	Overland Park Regional Medical Center	Kansas City District Office	CGMP/Deviations/Adulterated	N/A *
July 13, 2007	Quality Formulation Laboratories, Inc.	New Jersey District Office	Food Labeling/Adulterated	N/A *
July 11, 2007	Blue Star Fish Company	Florida District Office	Seafood HACCP/Adulterated	N/A *
July 11, 2007	Schering-Plough Animal Health Corporation	Center for Veterinary Medicine	Promotional Claims/False & Misleading/Misbranded	N/A *
July 11, 2007	International Seaworld, Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
July 10, 2007	Farmers Market of Bolivar, Missouri, Inc.	Kansas City District Office	Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
July 10, 2007	Juice Company, LLC	Florida District Office	Juice HACCP/Adulterated	N/A *
July 10, 2007	Foo Yuan Food Products Co., Inc	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
July 09, 2007	First Priority, Inc.	Chicago District Office	CGMP Regulation for Finished Pharmaceuticals/Adulterated	N/A *
July 05, 2007	Ham Produce and Seafood, Inc.	San Francisco District Office	Seafood HACCP/GMP for Foods/Adulterated	N/A *
July 03, 2007	Center for Spinal Disorders	Center for Devices and Radiological Health	Investigational Device Exemptions	N/A *
July 03, 2007	Linden, David, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
July 03, 2007	Medtronic, Inc.	Minneapolis District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
July 01, 2007	T.W. Enterprises, Inc.	Seattle District Office	Adulterated Food	N/A *
June 29, 2007	ZEO Health Ltd.	Center for Food Safety and Applied Nutrition	New Drugs/Claims	N/A *
June 27, 2007	George's Fish and Seafood	Dallas District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
June 26, 2007	Staar Surgical Company	Center for Devices and Radiological Health	Investigational Device Exemptions	N/A *
June 26, 2007	Preferred Freezer Services, Inc.	New Jersey District Office	Seafood HACCP/Adulterated	N/A *
June 26, 2007	Elanco Animal Health	Center for Veterinary Medicine	Veterinary Medicine	N/A *
June 26, 2007	J & T Dairy	Seattle District Office	Illegal Drug Residue	N/A *
June 25, 2007	J & J Seafood, Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
June 25, 2007	Innovative Spinal Technologies, Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 25, 2007	Sitek Research Laboratories	Center for Drug Evaluation and Research	GLP for non-clincal laboratory studies	N/A *
June 22, 2007	Wingrove, Frank A., D.D.S.	Center for Drug Evaluation and Research	Sponsor/Clinical Investigator	N/A *
June 21, 2007	Merial Limited	Center for Veterinary Medicine	Promotional Claims/New Drug/Misbranded	N/A *
June 19, 2007	Biomedicare, Inc.	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 19, 2007	Bodin's, Inc.	Minneapolis District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 19, 2007	JC's Fish and BBQ, Inc.	Dallas District Office	Seafood HACCP/Adulterated	N/A *
June 19, 2007	S & W Farms	Cincinnati District Office	Illegal Drug Residue	N/A *
June 14, 2007	Crystal Reflections International, Inc.	Los Angeles District Office	CGMP for Medical Devices/QS/Adulterated	N/A *
June 12, 2007	Tingle X-Ray Products, Inc.	New Orleans District Office	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
June 11, 2007	Bayer Health Care LLC	Center for Veterinary Medicine	Promotional Claims/False & Misleading/Misbranded	N/A *
June 08, 2007	Medion Diagnostic AG	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
June 06, 2007	Kevin Sharpe Farm	New York District Office	Illegal Drug Residue	N/A *
June 06, 2007	Biolog, Inc.	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
June 06, 2007	Number One Fish Market Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
June 05, 2007	Heska Corporation	Center for Veterinary Medicine	Promotional Claims False & Misleading/Misbranded	N/A *
June 05, 2007	Hand, Steve, M	Atlanta District Office	Edible Tissues/Adulterated	N/A *
June 04, 2007	Truluck's Seafood LTD	Florida District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 01, 2007	TheraLife, Inc	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/New Drug/Misbranded	N/A *
June 01, 2007	Dornier Medtech America, Inc.	Atlanta District Office	Medical Device Reporting Regulation/Misbranded	N/A *

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