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U.S. Department of Health and Human Services

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2007 Warning Letters

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
05/31/2007 Healthline Medical Products Inc [ARCHIVED] Florida District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
05/31/2007 Alerchek, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
05/30/2007 Vesole, David H., M.D., Ph.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
05/29/2007 Southern States Frederick Cooperative, Inc. [ARCHIVED] Baltimore District Office New Animal Drug/Adulterated/Misbranded N/A *
05/25/2007 Doon Elevator Company [ARCHIVED] Kansas City District Office CGMP Requirements For Medicated Feeds/Adulterated N/A *
05/24/2007 Panacea Products, LLC [ARCHIVED] New Orleans District Office New Drug/Labeling/False & Misleading Claims N/A *
05/24/2007 MedImmune, Inc. [ARCHIVED] Center for Biologics Evaluation and Research CGMP N/A *
05/23/2007 Eles, Gustav, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
05/17/2007 Quantimetrix Corporation [ARCHIVED] Los Angeles District Office CGMP Requirements for Medical Devices/Quality System Regulation N/A *
05/17/2007 KZ Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
05/15/2007 Diamond S Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
05/14/2007 Domestic Cheese Company, Inc. [ARCHIVED] San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
05/14/2007 METASURG [ARCHIVED] Dallas District Office CGMP for Medical Devices/QS/Adulterated N/A *
05/10/2007 CuraScript SD [ARCHIVED] Florida District Office CGMP N/A *
05/10/2007 Sacramento Radiology Medical Group, Inc. [ARCHIVED] San Francisco District Office Mammography Quality Standards Act N/A *
05/10/2007 Southwind Foods Company [ARCHIVED] Denver District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
05/09/2007 TOSOH AIA, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP N/A *
05/08/2007 St. Elizabeth Medical Center IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
05/08/2007 Verrier, Edward, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
05/08/2007 Bear Creek Veterinary Services [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
05/08/2007 Bridges, R. McIntyre, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
05/08/2007 El Reglano Seafood Corporation [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
05/08/2007 Ocho Rios Miami Inc. [ARCHIVED] Florida District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
05/07/2007 E.I. DuPont DeNemours and Company [ARCHIVED] Philadelphia District Office OTC Drug Labeling/New Drug/Misbranded N/A *
05/04/2007 Livestock Dealer [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
05/02/2007 Par 5 Dairy Denver District Office Illegal Drug Residue N/A *
05/01/2007 Italfoods, Inc. [ARCHIVED] San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
05/01/2007 Young View Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
04/30/2007 Wal-Med, Inc. [ARCHIVED] Seattle District Office Premarket Approval/Misbranded/Adulterated N/A *
04/26/2007 FAVPEP LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
04/26/2007 Silimed, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
04/26/2007 Medical Wire & Equipment Co (Bath), Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated N/A *
04/26/2007 MedEnclosure, L.L.C. [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
04/25/2007 Dan VanGrouw Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
04/25/2007 Plastics Management Corporation [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated N/A *
04/24/2007 Davol, Inc. [ARCHIVED] New England District Office CGMP for Medical Devices/QS/Adulterated N/A *
04/24/2007 Rhytec, Inc. [ARCHIVED] New England District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
04/24/2007 G&B Electronic Designs Limited [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
04/24/2007 Defibtech, LLC [ARCHIVED] New England District Office CGMP for Medical Devices/QS/Adulterated N/A *
04/24/2007 Fusion Brands International SRL [ARCHIVED] New Jersey District Office Drug Products/Labeling N/A *
04/17/2007 Langers Juice Co. [ARCHIVED] Los Angeles District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
04/17/2007 STM Trading Corporation [ARCHIVED] San Juan District Office Seafood HACCP/Adulterated N/A *
04/16/2007 Bothwell Regional Health Center [ARCHIVED] Kansas City District Office CGMP Deviations/Additional Standards for Human Blood and Blood Products/Adulterated N/A *
04/16/2007 Medico Labs, Inc. [ARCHIVED] New Jersey District Office CGMP/Deviations/Adulterated N/A *
04/13/2007 PharMEDium Services, LLC [ARCHIVED] Dallas District Office New Drug N/A *
04/12/2007 Sun Biomedical Laboratories, Inc. [ARCHIVED] New Jersey District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
04/10/2007 AmeriWater, Inc. [ARCHIVED] Cincinnati District Office Premarket Approval/Misbranded/Adulterated N/A *
04/10/2007 Kemp Cattle Dallas District Office Illegal Drug Residue N/A *
04/10/2007 Stroup, Steven L.,M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
04/09/2007 L & M Cattle Co. Dallas District Office Illegal Drug Residue N/A *

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