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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2005 Warning Letters

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Tobacco Retailer 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
July 29, 2005 ElderTech Solutions, LLC [ARCHIVED] Seattle District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
July 29, 2005 Access Genetics [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Notification Approval/Adulterated/Misbranded N/A *
July 27, 2005 Beam of Light Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Laser Product Performance Standard/Labeling N/A *
July 27, 2005 Superior Rehab Technology, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice/Adulterated/Misbranded N/A *
July 26, 2005 Maria Medeiros Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue /Adulterated N/A *
July 25, 2005 Morris Veterinary Center, PSC [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
July 25, 2005 Le Gourmet Lorrain, Inc. [ARCHIVED] Baltimore District Office Food Labeling/Misbranded N/A *
July 22, 2005 Merck & Company, Inc. [ARCHIVED] Office of Enforcement Biologics License/Adulterated N/A *
July 21, 2005 New England Marketers, Inc. dba Yankee Specialty Foods [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
July 21, 2005 ACS Dobfar [ARCHIVED] Center for Drug Evaluation and Research Current Good Manufacturing Practice Regulation/Adulterated N/A *
July 21, 2005 MJM International Corporation [ARCHIVED] Dallas District Office CGMP/QSR/Lacks Premarket Approval Application/Medical Device Reporting Regulation N/A *
July 19, 2005 Pacific Northwest Best Fish Company [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
July 19, 2005 SenoRx, Inc. [ARCHIVED] Los Angeles District Office CGMP Requirements for Medical Devices/Adulterated N/A *
July 19, 2005 Uroplasty, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
July 19, 2005 Beck Network, Inc. [ARCHIVED] New Orleans District Office Promotional Claims False & Misleading/New Drugs N/A *
July 18, 2005 Mercy Health System of Kansas, Inc. [ARCHIVED] Kansas City District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
July 18, 2005 American Medical Specialties, Inc. [ARCHIVED] Florida District Office Quality System Regulation for Medical Devices/Adulterated/Misbranded N/A *
July 13, 2005 Hitachi Medical Systems America, Inc. [ARCHIVED] Cincinnati District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated N/A *
July 11, 2005 Cape Drugs [ARCHIVED] Center for Drug Evaluation and Research Pharmacy Compounding/New Drug/Misbranded N/A *
July 08, 2005 Holmes By-Products Company, Inc. [ARCHIVED] Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
July 07, 2005 Medical Science Products, Inc. [ARCHIVED] Cincinnati District Office Quality System Reguation/Adulterated N/A *
July 07, 2005 Newport Seafoods Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
July 06, 2005 Smith Dairy [ARCHIVED] New Orleans District Office Illegal Drug Residue /Adulterated N/A *
July 06, 2005 Mark A. Frankle, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 06, 2005 Mark A. Mighell, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 06, 2005 Donald Pope Veal Farm [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
July 06, 2005 Orthometrix, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
July 01, 2005 Litron Laboratories, Ltd [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
July 01, 2005 Cytogen Corporation [ARCHIVED] Center for Drug Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
July 01, 2005 Blake Street Manufacturing, LLC [ARCHIVED] Denver District Office Food Labeling Misbranded N/A *
June 30, 2005 Global Manufacturing & Engineering, LLC [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice/Adulterated N/A *
June 29, 2005 Con-Med Corporation [ARCHIVED] Florida District Office Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded N/A *
June 29, 2005 CrestLab Inc. [ARCHIVED] Detroit District Office Current Good Manufacturing Practice/Adulterated N/A *
June 28, 2005 Kabobs, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
June 28, 2005 Bimeda MTC Animal Health Inc. [ARCHIVED] Center for Veterinary Medicine Current Good Manufacturing Practice Regulation/Adulterated N/A *
June 28, 2005 MedTec Inc [ARCHIVED] Kansas City District Office QSR/Medical Devices/Adulterated N/A *
June 27, 2005 Homen Dairy Farms, LP [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
June 24, 2005 Greer Laboratories, Inc. [ARCHIVED] Office of Enforcement CGMP for Finished Pharmaceutical N/A *
June 24, 2005 Georgia Biomedical, Inc. [ARCHIVED] Atlanta District Office Quality System Reguation/Adulterated N/A *
June 23, 2005 Khoury, Michael MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
June 23, 2005 Lee Medical International, Inc. [ARCHIVED] New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
June 23, 2005 St. John Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
June 22, 2005 Customed, Inc. [ARCHIVED] San Juan District Office CGMP for Medical Devices/QS/Adulterated N/A *
June 22, 2005 Certified Natural Laboratories, Inc. [ARCHIVED] Kansas City District Office Dietary Supplements/Labeling/Misbranded N/A *
June 21, 2005 Custom Ultrasonics, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
June 21, 2005 MedImmune Vaccines, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
June 21, 2005 Lake Erie Medical and Surgical, Inc. [ARCHIVED] Detroit District Office Current Good Mfg Practice Regulation/Adulterated/Misbranded N/A *
June 20, 2005 Food With Care Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
June 17, 2005 Pragmatic Materials, Inc. [ARCHIVED] Cincinnati District Office Active Pharmaceutical Ingredient/Adulterated N/A *
June 17, 2005 Chickering, Arthur H III [ARCHIVED] New England District Office Adulterated Animal Drugs/Misbranded N/A *

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ICECI Warning Letters

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Food and Drug Administration

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