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U.S. Department of Health and Human Services

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2000 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters for 2000

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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 20, 2000 Tripath Imaging Inc. [ARCHIVED] Center for Devices and Radiological Health AutoCyte PREP System/Promotional Claims N/A *
April 20, 2000 Gerben Leyendekker Dairy [ARCHIVED] San Francisco District Office Food/Cattle N/A *
April 19, 2000 Greeley Medical Clinic [ARCHIVED] Dallas District Office Mammography Standards N/A *
April 19, 2000 Adkinson N. Franklin Jr. M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
April 19, 2000 Allergan Inc. [ARCHIVED] Center for Devices and Radiological Health AMO PhacoFlex II Intraocular Lens/Promotional Claims/Lacks Application for PMA/Misbranded etc. N/A *
April 19, 2000 A & D Healthcare [ARCHIVED] New Orleans District Office Medical Oxygen / CGMP N/A *
April 19, 2000 Seldom Rest Farm [ARCHIVED] New York District Office Food/Cattle N/A *
April 19, 2000 Genesee Memorial Hospital [ARCHIVED] New York District Office Mammography Standards N/A *
April 19, 2000 Parkway Hospital Inc. [ARCHIVED] Dallas District Office Mammography Standards N/A *
April 19, 2000 North Colorado Medical Center [ARCHIVED] Dallas District Office Mammography Standards N/A *
April 18, 2000 Kubus Inc. [ARCHIVED] Kansas City District Office Artificial Insemination Aid/Unapproved New Animal Drug Application N/A *
April 18, 2000 Lew-Lin Farms [ARCHIVED] New York District Office Food/Cattle N/A *
April 18, 2000 Microvena Corporation [ARCHIVED] Minneapolis District Office Quality System Regulation/Amplatz Thrombectomy Devices N/A *
April 18, 2000 OmniCorder Technologies Inc. [ARCHIVED] Center for Devices and Radiological Health BioScan/Promotional Claims N/A *
April 18, 2000 Mentholatum Co. Inc. [ARCHIVED] New York District Office Migraine Ice/Unpproved Application for Premarket Approval N/A *
April 18, 2000 Kham Seafood [ARCHIVED] New Orleans District Office Seafood Processing Regulations/HACCP N/A *
April 17, 2000 Irasan Complex [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood Processing Regulations/HACCP N/A *
April 17, 2000 Sim-Med Ltd. [ARCHIVED] Center for Devices and Radiological Health Laser Product Performance Standard N/A *
April 17, 2000 Limberg Michael B. M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
April 14, 2000 Mission Bay Memorial Hospital/Institutional Review Board [ARCHIVED] Center for Devices and Radiological Health IRB (Institutional Review Board) N/A *



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ICECI Warning Letters

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Food and Drug Administration

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