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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 04, 2001 Holles Laboratories Inc. [ARCHIVED] New England District Office Quality System Regulation/Fluoresoft 0.35%/Adulterated N/A *
April 04, 2001 Centinela Medical Center of Fox Hills [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
April 03, 2001 Areias& Meneses Dairy [ARCHIVED] San Francisco District Office Dairy/Adulterated/Illegal Drug Residue N/A *
April 03, 2001 Johnson T.L. M.D. [ARCHIVED] Cincinnati District Office Mammography Standards N/A *
April 03, 2001 Rubin Arnold M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
April 03, 2001 Norbec [ARCHIVED] Center for Devices and Radiological Health Noiselezz Anti-Snoring Mouth Guard/Lacks Premarket Notification/Misbranded N/A *
April 03, 2001 Mountain Pride [ARCHIVED] Seattle District Office Seafood Processing Regulations/HACCP N/A *
April 03, 2001 Pediatric Services of America Inc [ARCHIVED] Atlanta District Office Medical Oxygen Transfilling/Adulterated N/A *
April 03, 2001 Insight Optical Manufacturing Co. [ARCHIVED] Florida District Office Spectacle Frames/Lacks"MayProceed Notice"or"Release Notice" N/A *
April 02, 2001 Safety & Compliance Consulting [ARCHIVED] Center for Devices and Radiological Health Laser Product Performance Standard N/A *
April 02, 2001 Kingsridge Medical Imaging [ARCHIVED] Cincinnati District Office Mammography Standards N/A *
April 02, 2001 Baptist Imaging Center [ARCHIVED] Dallas District Office Mammography Quality Standards N/A *
April 02, 2001 ORCHEM Corporation [ARCHIVED] Cincinnati District Office New Drug/Labeling/Misbranded/Adulterated N/A *
April 02, 2001 Juice Harvest Inc. [ARCHIVED] Los Angeles District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
April 02, 2001 Golden Fields EnterprisesInc. [ARCHIVED] Baltimore District Office Noodle Manufacturing Facility/Insanitary/Adulterated N/A *
April 02, 2001 Waldermar Link GmbH & Co. [ARCHIVED] Center for Devices and Radiological Health Joint Replacement Prostheses/Qiality System Regulation N/A *
March 30, 2001 Farmers Mill & Elevator Company [ARCHIVED] Atlanta District Office Animal Proteins Prohibited in Ruminant Feed N/A *
March 30, 2001 LM Sandler & Sons [ARCHIVED] Atlanta District Office Seafood HACCP/Crabmeat N/A *
March 30, 2001 Albert Lea Medical Center [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
March 30, 2001 Marian Community Hospital [ARCHIVED] Philadelphia District Office Mammography Quality Standards N/A *



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ICECI Warning Letters

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