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U.S. Department of Health and Human Services

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 31, 2003 Aqua Micron LLC [ARCHIVED] Denver District Office CGMP/Finished Pharmaceuticals/Adulterated N/A *
December 30, 2003 Sunja's Oriental Food Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
December 30, 2003 Billy's Sandwiches Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
December 30, 2003 Xttrium Laboratories, Inc. [ARCHIVED] Chicago District Office Postmarketing Reporting of Adverse Drug Experience N/A *
December 29, 2003 Orleans Poverty Hill Farm [ARCHIVED] New York District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
December 29, 2003 Zirlott's Gulf Products [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
December 29, 2003 Lordex Inc [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation N/A *
December 29, 2003 Mario M. Simoes Dairy #2 [ARCHIVED] San Francisco District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
December 29, 2003 Kos Pharmaceuticals, Inc. [ARCHIVED] New Jersey District Office Good Manufacturing Processing, Packing, Holding/Finished Pharmaceuticals/Adulterated N/A *
December 29, 2003 TJ Candy Corporation [ARCHIVED] Dallas District Office Import/Lacks "May Proceed" or "May Release" N/A *
December 23, 2003 Rusk County Memorial Hospital & Nursing Home [ARCHIVED] Minneapolis District Office GMP for Blood & Blood Components/Adulterated N/A *
December 23, 2003 Custom Compounding Centers [ARCHIVED] Center for Biologics Evaluation and Research Pharmacy Compounding/GMP for Finished Pharmaceuticals N/A *
December 23, 2003 IND Diagnostic, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP Requirements of the Quality System Regulations/Adulterated N/A *
December 23, 2003 Eldon Biologicals A/S [ARCHIVED] Center for Devices and Radiological Health CGMP Requirements of the Quality System Regulations/Adulterated N/A *
December 23, 2003 H.B. Williams, Inc. [ARCHIVED] Philadelphia District Office Illegal Drug Residue/Adulterated N/A *
December 23, 2003 Turner County Dairy, LLP [ARCHIVED] Minneapolis District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
December 22, 2003 Prescript Pharmaceuticals, Inc. [ARCHIVED] San Francisco District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
December 22, 2003 Stockpot Incorporated [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
December 22, 2003 Staar Surgical Company [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation N/A *
December 19, 2003 HNK, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *



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ICECI Warning Letters

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