2004 Warning Letters

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Warning Letters issued in 2004

 

* 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 May 04, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 01, 2004	Bearden Sandwich Co., Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
November 29, 2004	Novartis Animal Health Services AG	Atlanta District Office	Adverse Drug Experience Reporting Requirements	N/A *
November 29, 2004	Celsis Laboratory Group, St. Louis Division	Center for Drug Evaluation and Research	GLP for Non-Clinical Laboratory Studies	N/A *
November 24, 2004	Berne Hi Way Hatchery, Inc.	Detroit District Office	CGMP for Medicated Feeds/Adulterated	N/A *
November 24, 2004	Sooil Development Co., Ltd	Center for Devices and Radiological Health	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 23, 2004	Kegelmaster 2000 Ltd.	Florida District Office	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
November 23, 2004	Thuemmel Dairy, Inc.	Detroit District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
November 22, 2004	Aurora Imaging Technology, Inc.	New England District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
November 22, 2004	LAR Manufacturing, LLC	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
November 22, 2004	Moshirfar, Majid, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
November 22, 2004	Miracle Fish, Inc.	Florida District Office	Seafood HACCP	N/A *
November 19, 2004	Protherics, Inc.	Center for Biologics Evaluation and Research	Promotional Claims/False & Misleading	N/A *
November 19, 2004	Ortek AG	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
November 19, 2004	Pharmachem Laboratories, Inc.	New Jersey District Office	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
November 19, 2004	Jomara Seafood, Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
November 19, 2004	DiGiorgio Corp.	New Jersey District Office	Seafood HACCP/Adulterated	N/A *
November 19, 2004	Ferndale Laboratories, Inc.	Detroit District Office	Lacks Approved New Drug Application/Labeling/Misbranded	N/A *
November 19, 2004	ATF Fitness Products, Inc.	Philadelphia District Office	Dietary Supplement/Labeling/Adulterated	N/A *
November 19, 2004	Osprey Seafood of California, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
November 18, 2004	LA Dorada Coral Gables, Inc.	Florida District Office	Seafood HACCP	N/A *
November 18, 2004	Parrish & Heimbecker Limited	Seattle District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded	N/A *
November 17, 2004	Community Hospital & Rehabilitation Center of Los Gatos	San Francisco District Office	Mammography Quality Standards	N/A *
November 17, 2004	Nuclear Cardio Systems, Inc.	Denver District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 17, 2004	Constantine, Niel T., Ph.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 17, 2004	Pajunk GmbH	Center for Devices and Radiological Health	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
November 17, 2004	Amsterdam, Daniel, Ph.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 16, 2004	MED-EL ELEKTRO-MEDIZINISCHE GERATE GmbH	Center for Devices and Radiological Health	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 15, 2004	Upscale Foods, Inc.	Minneapolis District Office	Food Labeling/Misbranded	N/A *
November 12, 2004	Clarity, Inc.	New Orleans District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 10, 2004	Alveolus, Inc.	Atlanta District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
November 09, 2004	South Florida Medical Corporation	Florida District Office	CGMP for Oxygen/Manufacturing, processing, packing, storage & holding/Adulterated	N/A *
November 09, 2004	Germiphene Corporation	Center for Devices and Radiological Health	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 09, 2004	Northern Implants L.L.C.	Baltimore District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 08, 2004	AMF Support Surfaces, Inc.	Los Angeles District Office	Lacks Approved Premarket Application/Adulterated	N/A *
November 08, 2004	Spandet Dairy, Inc.	Dallas District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
November 05, 2004	Synthes, Inc.	Center for Devices and Radiological Health	CGMP/QSR/Medical Device Reporting/Adulterated	N/A *
November 05, 2004	VitalCare Group, Inc.	Florida District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 05, 2004	Purington, Timothy W.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 04, 2004	Kaiser Permanente Medical Center-Vallejo	San Francisco District Office	Mammography Quality Standards	N/A *
November 03, 2004	Great Atlantic Trading	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
November 02, 2004	Reid's Bus Service	Kansas City District Office	Interstate Conveyance Sanitation Regulations	N/A *
November 02, 2004	Blood Net USA, Inc.	Florida District Office	CGMP for Blood & Blood Components/Adulterated	N/A *
November 02, 2004	Liko, Inc.	New England District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
November 02, 2004	Rhody Dairy	Seattle District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
November 01, 2004	Shin Chang Medical Co., Ltd.	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
November 01, 2004	ABC Compounding Company, Inc.	Atlanta District Office	Lacks Approved New Drug Application/Adulterated/Misbranded	N/A *
October 29, 2004	VitalCare Group, Inc.	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
October 28, 2004	Henry, Gary	Cincinnati District Office	CGMP for Medicated Feeds/Unapproved New Animal Drug/Adulterated	N/A *
October 27, 2004	Rick's Gulf Tex Seafood, Inc.	Dallas District Office	Seafood HACCP/Adulterated	N/A *
October 26, 2004	The One and Only Fashion Beauty Group, Inc.	Center for Devices and Radiological Health	Contact Lenses/Labeling/Adulterated/Misbranded	N/A *

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