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
August 08, 2007	Swanson Health Products, Inc.	Minneapolis District Office	Dietary Supplements	N/A *
August 08, 2007	Novis PR dba Kramer-Novis	San Juan District Office	OTC Drug Products/Dietary Supplements/Misbranded	N/A *
August 07, 2007	Sunburst Biorganics	New York District Office	Dietary Supplements	N/A *
August 02, 2007	Cook's Seafood Company	Baltimore District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
August 01, 2007	Sunoptic Technologies, LLC	Florida District Office	CGMP for Medical Devices/Adulterated	N/A *
July 31, 2007	Bay Valley Foods, LLC	Philadelphia District Office	Acidified Foods/Adulterated	N/A *
July 31, 2007	Riverfront Fish Market	Dallas District Office	Seafood HACCP	N/A *
July 31, 2007	Genaros Seafood, Inc.	Florida District Office	Seafood HACCP/Adulterated/Misbranded	N/A *
July 30, 2007	GMI European Food Distributors Inc.	New England District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
July 30, 2007	Pulse Biomedical, Inc.	Philadelphia District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
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 *

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