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
July 29, 2004	A-1 Sandwich Wholesale Co.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
July 29, 2004	Jacobs Ranch L.L.C.	Dallas District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 29, 2004	Nottenkamper, Joe	Dallas District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 29, 2004	Stoll Farms, Inc.	Cincinnati District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 28, 2004	Haifa Smoked Fish, Inc.	New York District Office	Seafood HACCP/Adulterated	N/A *
July 28, 2004	First Quality Hygenics, Inc.	Philadelphia District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
July 28, 2004	Mar, Timothy P., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 27, 2004	Levittown Fish Market	Florida District Office	Seafood HACCP	N/A *
July 27, 2004	Warehouse Food Group, LLC	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
July 26, 2004	Toledo, Jose Gregorio	San Juan District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 26, 2004	Sierra Dairy	Dallas District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 26, 2004	Bio Compression Systems	New Jersey District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
July 26, 2004	Double J Livestock	Baltimore District Office	Sale for Slaughter as Food/Adulterated	N/A *
July 26, 2004	Kioschos, Hans C., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 26, 2004	Tenacore Holdings, Inc.	Los Angeles District Office	Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated	N/A *
July 23, 2004	DANA Diabecare USA LLC	New Orleans District Office	Medical Device Reporting/Misbranded	N/A *
July 22, 2004	Beck Farms, LP	New York District Office	Illegal Drug Residue Animal Tissue/Extra-Label Drug Use/Adulterated	N/A *
July 22, 2004	Ultra-Seal Corporation	New York District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
July 22, 2004	Brotherhood Farms	New York District Office	Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use	N/A *
July 21, 2004	Modesto Fish Company	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
July 21, 2004	Lextron Texas LLP	Dallas District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
July 21, 2004	Chios Bakery, Inc.	Baltimore District Office	CGMP/Deviations/Adulterated	N/A *
July 20, 2004	Hidden Valley Dairy	Seattle District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 20, 2004	Love and Quiches, Ltd.	New York District Office	Interstate Conveyance Sanitation/GMP Mfr, Packing, Holding Food	N/A *
July 19, 2004	OST Medical, Inc.	New England District Office	Lacks Premarket Approval/Adulterated/Misbranded	N/A *
July 19, 2004	Marquez, Raul A., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 19, 2004	Amstutz, Harlan C., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 19, 2004	Nutraceutical International Corporation	Denver District Office	Food/Adulterated	N/A *
July 16, 2004	Philips Lighting B.V.	Center for Devices and Radiological Health	CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation	N/A *
July 16, 2004	The Gourmet Padre	Atlanta District Office	Food Labeling Misbranded	N/A *
July 16, 2004	Stonington Sea Products, Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
July 16, 2004	Aap Implantate AG	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
July 15, 2004	Airway Clearing Tools	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
July 14, 2004	Inceptio Medical Technologies, L.C.	Denver District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
July 14, 2004	Expanded Vision	Center for Devices and Radiological Health	Lacks Premarket Approval/Adulterated/Misbranded	N/A *
July 14, 2004	Buns Master Bakery, Inc.	Seattle District Office	Food Labeling/Adulterated/Misbranded	N/A *
July 14, 2004	Croley, Thomas L., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 13, 2004	Smoot, John Brannon, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 13, 2004	Gentere, Inc.	Cincinnati District Office	Pharmacy Compounding/GMP/Adulterated/Drug Labeling, Registration/Misbranded	N/A *
July 13, 2004	Peters, Thomas, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 13, 2004	Evermed Corporation	Los Angeles District Office	Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated	N/A *
July 13, 2004	Roy and Gladice Luth Farm	Chicago District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 12, 2004	Central Florida Eye Institute	Center for Devices and Radiological Health	Institutional Review Board	N/A *
July 12, 2004	Illini Feeds, Inc.	Chicago District Office	Animal Proteins Prohibited in Ruminant Feed/Misbranded	N/A *
July 08, 2004	Bounty Seafood	New England District Office	Seafood HACCP/Adulterated	N/A *
July 08, 2004	Avon Seafood	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
July 08, 2004	Sansone's Seafood Market, Inc.	Philadelphia District Office	Seafood HACCP/Adulterated	N/A *
July 08, 2004	BioMerieux, Inc.	Atlanta District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
July 07, 2004	Glustitch Incorporated	Center for Devices and Radiological Health	GMP Requirements for Quality System Regulation/Dental Products/Adulterated	N/A *
July 07, 2004	Cordis Corporation	Center for Devices and Radiological Health	Sponsor Obligations	N/A *

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