2003 Warning Letters

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Warning Letters issued in 2003

 

* 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 05, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 31, 2003	Aqua Micron LLC	Denver District Office	CGMP/Finished Pharmaceuticals/Adulterated	N/A *
December 30, 2003	Xttrium Laboratories, Inc.	Chicago District Office	Postmarketing Reporting of Adverse Drug Experience	N/A *
December 30, 2003	Billy's Sandwiches Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
December 30, 2003	Sunja's Oriental Food Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
December 29, 2003	Mario M. Simoes Dairy #2	San Francisco District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
December 29, 2003	TJ Candy Corporation	Dallas District Office	Import/Lacks "May Proceed" or "May Release"	N/A *
December 29, 2003	Kos Pharmaceuticals, Inc.	New Jersey District Office	Good Manufacturing Processing, Packing, Holding/Finished Pharmaceuticals/Adulterated	N/A *
December 29, 2003	Zirlott's Gulf Products	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
December 29, 2003	Lordex Inc	Dallas District Office	Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation	N/A *
December 29, 2003	Orleans Poverty Hill Farm	New York District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
December 23, 2003	Rusk County Memorial Hospital & Nursing Home	Minneapolis District Office	GMP for Blood & Blood Components/Adulterated	N/A *
December 23, 2003	Turner County Dairy, LLP	Minneapolis District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
December 23, 2003	H.B. Williams, Inc.	Philadelphia District Office	Illegal Drug Residue/Adulterated	N/A *
December 23, 2003	Custom Compounding Centers	Center for Biologics Evaluation and Research	Pharmacy Compounding/GMP for Finished Pharmaceuticals	N/A *
December 23, 2003	IND Diagnostic, Inc.	Center for Devices and Radiological Health	CGMP Requirements of the Quality System Regulations/Adulterated	N/A *
December 23, 2003	Eldon Biologicals A/S	Center for Devices and Radiological Health	CGMP Requirements of the Quality System Regulations/Adulterated	N/A *
December 22, 2003	Staar Surgical Company	Los Angeles District Office	Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation	N/A *
December 22, 2003	Prescript Pharmaceuticals, Inc.	San Francisco District Office	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated	N/A *
December 22, 2003	Stockpot Incorporated	Seattle District Office	Seafood HACCP/Adulterated	N/A *
December 19, 2003	HNK, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
December 19, 2003	Capital Candy Co., Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
December 18, 2003	Fairfield Farm Kitchens Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
December 18, 2003	Schell's Pine Grove Dairy	Minneapolis District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
December 18, 2003	Joe M. Simoes Family Dairy	San Francisco District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
December 17, 2003	Joharra Dairy Farms	Los Angeles District Office	Illegal Drug Residue Animal Tissue/Adulterated	N/A *
December 17, 2003	The Net Result	New England District Office	Seafood HACCP/Adulterated	N/A *
December 17, 2003	Jesse's Bakery, Inc.	San Francisco District Office	GMP for Food/Food Labeling/Misbranded/Adulterated	N/A *
December 16, 2003	Nutralife Laboratories	Los Angeles District Office	New Drug/Nutrition Labeling Dietary Supplements/Misbranded	N/A *
December 16, 2003	Russo's Seafood, Inc.	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
December 16, 2003	The Food Shop Inc.	New England District Office	Food Labeling/Seafood HACCP/Misbranded/Adulterated	N/A *
December 15, 2003	Absolute Packaging Inc	Florida District Office	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated	N/A *
December 15, 2003	Central Missouri Agri-Service LLC	Kansas City District Office	Medicated Feeds/Adulterated	N/A *
December 15, 2003	Jumbo Foods	Seattle District Office	Seafood HACCP/Adulterated	N/A *
December 12, 2003	Floyd Poche Enterprises, Inc.	New Orleans District Office	Food Labeling/Undeclared Ingredients/Misbranded	N/A *
December 11, 2003	Ecologic	Center for Food Safety and Applied Nutrition	False & Misleading Claims/New Drug/Misbranded	N/A *
December 11, 2003	Caldwell, Stephen H., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 11, 2003	New York Eye & Ear Infirmary	Center for Devices and Radiological Health	Institutional Review Board	N/A *
December 11, 2003	Smith Sterling Dental Laboratory, Inc.	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
December 10, 2003	Horst's Seafood Co., Inc.	Seattle District Office	Seafood HACCP/Adulterated	N/A *
December 09, 2003	James Hook & Co., LLC	New England District Office	Seafood HACCP/Adulterated	N/A *
December 09, 2003	Natures Hand	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
December 09, 2003	Southside Community Hospital	Baltimore District Office	Blood & Blood Products/Adulterated	N/A *
December 08, 2003	Charlie Seafood, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
December 08, 2003	Western Missouri Medical Center	Kansas City District Office	Blood Bank/GMP for Blood & Blood Components	N/A *
December 04, 2003	Odyssey Medical Inc.	New Orleans District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
December 04, 2003	Philippine Food Distributor	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
December 04, 2003	Sun Valley Jerseys	Los Angeles District Office	Illegal Drug Residue Animal Tissue/Extralabel Use/Adulterated	N/A *
December 04, 2003	Dairyland Milk Company	Los Angeles District Office	Illegal Drug Residue/Adulterated	N/A *
December 03, 2003	Medron, Inc.	Denver District Office	Quality System Reguation/Adulterated	N/A *
December 03, 2003	Kral X-Ray, Inc	Atlanta District Office	Performance Standard for Ionizing Radiation Emitting Products	N/A *

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