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
September 21, 2007	Imperial Food Services, Inc.	Chicago District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
September 20, 2007	Toms, Matthew	Baltimore District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
September 19, 2007	Zinnanti Surgical Design, LLC	Philadelphia District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 19, 2007	Genzyme Corporation	Center for Biologics Evaluation and Research	CGMP Deviations	N/A *
September 18, 2007	Amato, Robert J., D.O.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
September 14, 2007	Procter and Gamble	Cincinnati District Office	Labeling/OTC Drugs	N/A *
September 11, 2007	Universal Enterprises, Inc.	San Francisco District Office	Interstate Conveyance Sanitation/Control of Communicable Disease	N/A *
September 11, 2007	American Nutrition, Inc	Denver District Office	Animal Food/Misbranded/Labeling	N/A *
September 11, 2007	Tembec, Inc.	Cincinnati District Office	Food Additive/Adulterated/Misbranded	N/A *
September 10, 2007	Murvest, Inc.	Florida District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
September 07, 2007	North Coast Medical Inc.	San Francisco District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 06, 2007	Danmar Product, Inc.	Detroit District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
September 06, 2007	Kunshan Chemical and Pharmaceutical Co., Ltd.	Center for Drug Evaluation and Research	CGMP for Finished Pharmaceuticals/Deviations/Adulterated	N/A *
September 04, 2007	Sorenson Medical, Inc.	Denver District Office	CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded	N/A *
September 04, 2007	Tobler, William D., MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
August 30, 2007	Melanocorp, Inc.	New Orleans District Office	Drug/Lacks Approved Application	N/A *
August 30, 2007	Millner Trading Company, Inc.	Philadelphia District Office	Acidified Foods	N/A *
August 30, 2007	Boston Scientific Cardiovascular	Center for Devices and Radiological Health	Investigational Device Exemptions	N/A *
August 29, 2007	Ochsner Clinic Foundation	New Orleans District Office	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products	N/A *
August 29, 2007	Fish Busterz L.L.C	Florida District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *

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