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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
June 05, 2001 Fauquier Hospital Inc. [ARCHIVED] Baltimore District Office Mammography Quality Standards N/A *
June 04, 2001 Lucky Tours [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation N/A *
June 04, 2001 Alfa Scientific Designs Inc. [ARCHIVED] Los Angeles District Office In Vitro Diagnostic Kits/Quality System Regulation N/A *
June 04, 2001 John Nagle Company [ARCHIVED] New England District Office Seafood HACCP/Vacuum Packed Fresh Fish N/A *
June 04, 2001 Stockton Diagnostic Imaging [ARCHIVED] San Francisco District Office Mammography Quality Standards N/A *
June 04, 2001 South Cape Seafood Inc [ARCHIVED] New England District Office Seafood HACCP N/A *
June 04, 2001 Hansen Beverage Company [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Misbranded N/A *
June 04, 2001 OraLabs Inc. [ARCHIVED] Atlanta District Office Cholesterx/Lacks Approved New Drug Application/Misbranded N/A *
June 04, 2001 Fresh Samantha Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Misbranded N/A *
June 04, 2001 Barlean's Organic Oils LLC [ARCHIVED] Seattle District Office Food Labeling/Lacks New Drug Application/Misbranded N/A *
June 01, 2001 St. Elizabeth Medical Group [ARCHIVED] New York District Office Mammography Quality Standards N/A *
June 01, 2001 Oregon Rail Holdings LLC [ARCHIVED] Los Angeles District Office Interstate Conveyance Sanitation N/A *
June 01, 2001 Ocean Fishery Trading [ARCHIVED] Los Angeles District Office Seafood HACCP/GMP Requirements for Foods N/A *
June 01, 2001 Lehman Foods Inc. [ARCHIVED] Los Angeles District Office Food Handling & Sanitation Practice/Bacteria Contamination/Adulterated N/A *
May 31, 2001 E-Med Innovations Inc [ARCHIVED] Center for Devices and Radiological Health E-Steth/Lacks Application for Premarket Approval/Adulterated/Misbranded N/A *
May 31, 2001 Ron Smith Seafood Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Fresh Tuna and Mahi Mahi N/A *
May 31, 2001 KCC Enterprises [ARCHIVED] Center for Devices and Radiological Health Instant Drug Test/Adulterated/Misbranded N/A *
May 31, 2001 Sole Provider Inc. [ARCHIVED] New England District Office Seafood HACCP/Ready-to-Eat Crabmeat N/A *
May 30, 2001 Felicia Foods LLC [ARCHIVED] New York District Office Pickled Ginger/Unapproved Food Additive/Adulterated N/A *
May 30, 2001 The Scoular Company [ARCHIVED] Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed N/A *



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ICECI Warning Letters

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