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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
May 24, 2000 APS (USA) Ltd. [ARCHIVED] Center for Devices and Radiological Health Action Potential Stimulation Therapy Device/Promotional Claims/Lacks Premarket Approval/Misbranded N/A *
May 24, 2000 Del Monte Fresh Produce Inc. [ARCHIVED] New Jersey District Office Potable Water Hydrants/Backflow Prevention Devices/Violations N/A *
May 24, 2000 Casix in USA [ARCHIVED] Center for Devices and Radiological Health Federal Performance Standard for Laser Products N/A *
May 24, 2000 Cummins Howard S. Ph.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
May 24, 2000 Medtronic Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
May 24, 2000 Macek Anne L. M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
May 23, 2000 CIBA Vision Corporation [ARCHIVED] San Juan District Office Good Manufacturing Practice Regulaitons for Finished Pharmaceutical/Ophthalmic Drug Products N/A *
May 22, 2000 Polynesian Natural Health Products LLC [ARCHIVED] Los Angeles District Office Pol'Noni/Promotional Claims/Labeling/Lacks Approved New Drug Application/Misbranded N/A *
May 22, 2000 International Medication Systems Limited [ARCHIVED] Los Angeles District Office CGMP/Finished Pharmaceuticals N/A *
May 22, 2000 Templeton Feed and Grain [ARCHIVED] Los Angeles District Office Medicated Feed Manufacturing Facility N/A *
May 22, 2000 Price's Power International Inc. [ARCHIVED] Baltimore District Office Predator Chromium Picolinate & Power Plus Natural Phen-Fen/Lacks New Drug Application/Therapeutic Cl N/A *
May 22, 2000 George Washington University Hospital [ARCHIVED] Baltimore District Office Mammography Standards N/A *
May 22, 2000 Miter Inc. [ARCHIVED] Detroit District Office Failure to Comply with Device Quality System Regulation N/A *
May 22, 2000 I.S.P. Company Inc. [ARCHIVED] Baltimore District Office Unapproved New Drug Human Animal/GMP/Adulterated/Misbranded N/A *
May 19, 2000 Fluvanna Correctional Center for Women [ARCHIVED] Baltimore District Office Mammography Standards N/A *
May 19, 2000 Americair East Bay [ARCHIVED] San Francisco District Office Medical Oxygen / CGMP N/A *
May 19, 2000 Phazx Systems Inc. [ARCHIVED] Center for Devices and Radiological Health Body Scan 2010 VLD-100/Promotional Material/False and Misleading etc. N/A *
May 19, 2000 West Coast Radiology Center [ARCHIVED] Los Angeles District Office Mammography Standards N/A *
May 18, 2000 Big Shy Farms [ARCHIVED] Minneapolis District Office Food/Cattle N/A *
May 18, 2000 Dr. Pepper/Seven Up Inc. [ARCHIVED] Dallas District Office Labeling/Misbranded N/A *



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ICECI Warning Letters

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