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U.S. Department of Health and Human Services

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2001 Warning Letters

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Warning Letters for 2001

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* 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
April 12, 2001 Healthsouth Diagnostic Center of Front Range [ARCHIVED] Dallas District Office Mammography Quality Standards N/A *
April 12, 2001 Adams County Memorial Hospital [ARCHIVED] Minneapolis District Office Mammography Quality Standards N/A *
April 12, 2001 Hanmi Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
April 12, 2001 St. Luke's Roosevelt Hospital Center [ARCHIVED] New York District Office Blood Bank/Standard Operating Procedures N/A *
April 12, 2001 Maricopa Medical Center [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
April 12, 2001 Eagle Distributors Inc. [ARCHIVED] Chicago District Office Seafood HACCP N/A *
April 12, 2001 Appleton Medical Center [ARCHIVED] Minneapolis District Office Mammography Quality Standards N/A *
April 12, 2001 Intuitive Surgical Incorporated [ARCHIVED] Center for Devices and Radiological Health Lacks Approved Premarket Approval Application/Da Vinci Surgical Systemn/Adulterated/Misbranded N/A *
April 12, 2001 Areias & Meneses Diary [ARCHIVED] San Francisco District Office Dairy/Illegal Drug Residue/Adulterated N/A *
April 11, 2001 Wright Medical Technology Inc. [ARCHIVED] Center for Devices and Radiological Health AlloMatrix/Lacks Approved Premarket Application/Adulterated N/A *
April 11, 2001 Omicron Quimica S.A. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Manufacturing Facility/Active Pharmaceutical Ingredient N/A *
April 11, 2001 Minor and James Medical PLLC [ARCHIVED] Seattle District Office Mammography Quality Standards N/A *
April 10, 2001 Ocean Beauty Seafoods Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Whole Cooked Crab and Fresh Tuna N/A *
April 10, 2001 Ocean Beauty Seafoods, Inc. Seattle District Office Seafood HACCP/Whole Cooked Crab and Fresh Tuna N/A *
April 10, 2001 Sinco Inc. [ARCHIVED] New England District Office Canned Tune/Entry Not Held Intact N/A *
April 10, 2001 GE Medical Systems Inc. SA [ARCHIVED] Center for Devices and Radiological Health Quality System Regulations/Full Field Digital Mammography System/Adulterated N/A *
April 10, 2001 Classic Care Products Inc. [ARCHIVED] New Orleans District Office Veterinary Drug Manufacturing Facility/CGMP's for Finished Pharmaceuticals N/A *
April 10, 2001 Minister Farmers Cooperative Exchange Inc. [ARCHIVED] Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill N/A *
April 10, 2001 Skintech 2000 Inc. [ARCHIVED] Florida District Office Lack Approved Premarket Approval Application/Blue Cap Spray N/A *
April 10, 2001 Miami River Lobster and Stone Crab [ARCHIVED] Florida District Office Seafood HACCP/Cooked Lobster N/A *



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ICECI Warning Letters

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