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 *

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