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
March 02, 2004	Per-Tech, Inc.	Minneapolis District Office	QSR/Adulterated/Undeclared Ingredient/Misbranded	N/A *
March 02, 2004	Ocuserv Instruments Inc.	New York District Office	Quality System Regulation/Medical Devices/Adulterated	N/A *
March 01, 2004	MedRx, Inc.	Florida District Office	QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated	N/A *
February 27, 2004	Pharmpak, Inc.	San Francisco District Office	GMP for Finished Pharmaceuticals/Drug Repackaging/Adulterated	N/A *
February 26, 2004	DynaMedics Corporation	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
February 26, 2004	Epicenter Dairy	Denver District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
February 25, 2004	Fay's Foods, Inc.	Los Angeles District Office	GMP in Manufacturing, Packing, Holding Human Food/Adulterated	N/A *
February 25, 2004	Premier Medical	Philadelphia District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
February 25, 2004	Maple Dairy	San Francisco District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
February 24, 2004	TMJ Implants, Inc.	Denver District Office	Medical Device Reporting Regulation/Misbranded	N/A *
February 24, 2004	Obsidian Medical Technology Inc.	San Francisco District Office	Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
February 24, 2004	Quintana Hermanos Inc.	San Juan District Office	Seafood HACCP/Adulterated	N/A *
February 24, 2004	Sea Win, Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
February 20, 2004	Gumbo Brothers Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
February 20, 2004	United Feeds, Inc.	Chicago District Office	Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
February 20, 2004	Cardio Display Corporation	New York District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
February 18, 2004	Global Internet Alliance	Dallas District Office	Unapproved New Drug/Misbranded	N/A *
February 18, 2004	Discount Prescriptions from Canada, Inc.	Center for Drug Evaluation and Research	Illegal Canadian Drug Importation	N/A *
February 17, 2004	Wing Kee Foodstuff Company	San Francisco District Office	GMP in Manufacturing, Packing, Holding Food/Adulterated	N/A *
February 13, 2004	Mid-Atlantic Diagnostics	Center for Devices and Radiological Health	Lack Approved Premarket Clearance/Adulterated/Misbranded	N/A *
February 13, 2004	MacKnight Smoked Foods, Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
February 12, 2004	Sullivan, J Ralph	Dallas District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
February 12, 2004	Marine Polymer Technologies, Inc.	Center for Devices and Radiological Health	Lacks Premarket Approval/Adulterated	N/A *
February 11, 2004	Harvey Kliebert Plant	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
February 11, 2004	Osteomed, LP	Dallas District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
February 11, 2004	S & H Dairy	San Francisco District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
February 10, 2004	Shanghai Medical Ltd	Center for Drug Evaluation and Research	CGMP/Active Pharmaceutical Ingredients/Adulterated	N/A *
February 09, 2004	Phillips Cattle Company	Los Angeles District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
February 09, 2004	Superior Cattle Feeders LLC	Los Angeles District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
February 05, 2004	Ehrlich, Randall V., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
February 05, 2004	Gel-Med International	Center for Devices and Radiological Health	QSR/Lacks Premarket Approval Application/Adulterated/Misbranded	N/A *
February 05, 2004	Home Sushi Bar	Seattle District Office	Seafood HACCP/Adulterated	N/A *
February 04, 2004	Domel Laboratories	San Juan District Office	Promotional Claims/False & Misleading	N/A *
February 04, 2004	Lagler Dairy	Seattle District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
February 04, 2004	Lombardi's Seafood Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
February 04, 2004	Domel Laboratories	San Juan District Office	OTC Drug Labeling/New Drug/Misbranded	N/A *
February 04, 2004	Hydropure Systems Inc	Florida District Office	QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated	N/A *
February 04, 2004	Greenwell Farms	Cincinnati District Office	GMP in Manufacturing, Packing, Holding Food/Adulterated	N/A *
February 04, 2004	Mortillaro Lobster Company, LLC	New England District Office	Seafood HACCP/Adulterated	N/A *
February 04, 2004	Rel's Foods Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
February 04, 2004	Grindstone Neck of Maine, LLC	New England District Office	Seafood HACCP/Adulterated	N/A *
February 03, 2004	Chestertown Animal Hospital	Baltimore District Office	Illegal Drug Residue, Animal Tissue/Extra Label Drug Use	N/A *
February 03, 2004	Zuka Trading and Distribution Company	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
February 02, 2004	Almil Nutritional Products, Inc.	Los Angeles District Office	GMP Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated/Misbranded	N/A *
February 02, 2004	Amros the Second, Inc.	New Jersey District Office	Seafood HACCP/GMP for Foods/Adulterated	N/A *
February 01, 2004	Refflex Technologies, Inc.	Florida District Office	Quality System Regulation/Adulterated/Misbranded	N/A *
January 30, 2004	World Health Products, LLC	New England District Office	Unapproved New Drug/Misbranded	N/A *
January 30, 2004	S & F Enterprises	Baltimore District Office	GMP in Manufacturing, Packing, Holding Food/Adulterated	N/A *
January 30, 2004	Better Than Formula, Inc.	Detroit District Office	Infant Formula/Misbranded	N/A *
January 30, 2004	Makevale Limited	Center for Devices and Radiological Health	Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded	N/A *

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