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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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
March 09, 2001 Possis Medical Inc. Minneapolis District Office Quality Sytem Regulation/Thrombectomy Catheter Systems/Adulterated N/A *
March 09, 2001 East Texas Medical Center-Pittsburg Dallas District Office Mammography Standards N/A *
March 09, 2001 Robert H. Klaus Farm Chicago District Office Food/Cattle/Adulterated N/A *
March 09, 2001 Kimberly-Clark Corporation Denver District Office Quality System Regulation/Good Manufacuring Practice/Medical Devices/Adulterated N/A *
March 09, 2001 Hilmes Robert F. Chicago District Office Food/Cattle/Adulterated N/A *
March 09, 2001 Das Gupta Tapas M.D. Ph.D Center for Biologics Evaluation and Research Clinical Investigator N/A *
March 09, 2001 Savant Medical Supply Inc. Chicago District Office CGMP/Finished Pharmaceuticals/Oxygen Transfilling Facility/Adulterated N/A *
March 09, 2001 Century Foods International Inc. Minneapolis District Office Acidified Dairy Products/Misbranded N/A *
March 08, 2001 Carper Frank New Jersey District Office Food/Horse N/A *
March 08, 2001 Downeast Pasta New England District Office Labeling/Misbranded N/A *
March 08, 2001 Prestage Farms Inc. New Orleans District Office Meicated Feeds N/A *
March 08, 2001 Sunrise Meats and Lockers Seattle District Office Seafood HACCP/Vacuum-Packaged Hot Smoked Seafood Products N/A *
March 08, 2001 Creighton Family Healthcare-South Dallas District Office Mammography Standards N/A *
March 07, 2001 Orange Imaging Medical Group Los Angeles District Office Mammography Standards N/A *
March 07, 2001 Safety Disposal System Inc. Florida District Office Quality System Regulations/Reusable Sharps Containers/Adulterated N/A *
March 07, 2001 St. Mary's Medical Center Center for Devices and Radiological Health Institutional Review Board N/A *
March 07, 2001 Barnes Health Care Services Atlanta District Office Medical Oxygen/Adulterated N/A *
March 07, 2001 Shields Feed and Supply Company New Orleans District Office Animal Proteins Prohibited in Ruminant Feed N/A *
March 06, 2001 Paddock LaboratoriesInc. Minneapolis District Office CGMP/Finished Pharmaceuticals N/A *
March 06, 2001 MPTF Toluca Lake Health Center Los Angeles District Office Mammography Standards N/A *



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ICECI Warning Letters

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