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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2006 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
October 16, 2006 Sylomar Phytoceuticals [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Red River Seafood & Deli [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
October 12, 2006 Sportron Training Center [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Pulsecast Ineractive Corp [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Radiometer America, Inc. [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation N/A *
October 12, 2006 NATR, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 MicroNutraHealth [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Progessive Health Nutraceuticals, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Healthy-Living.org [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Hale Wai Oia, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 H & L World Wide Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Ziegler, Brookelyn [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 FulLife Natural Options, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Health Sites, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Nutricell, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Healing Edge Science [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 HEE Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Geromatrix [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Sportron International, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Native Remedies, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 European Solutions [ARCHIVED] Center for Food Safety and Applied Nutrition Drug Labeling/Promotional Claims/Misbranded N/A *
October 12, 2006 Enhansulin.com Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Wellness Support Network [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 LBJ Tropical Medical Center [ARCHIVED] San Francisco District Office Mammography Quality Standards N/A *
October 12, 2006 Sweet Sunnah Black Seef [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Albano, Brenda [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Annie Rose, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Lein, David A., MD [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
October 12, 2006 HerbsForLiving.com [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 12, 2006 Goldberg, David [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 11, 2006 NeuroScience, Inc. [ARCHIVED] Minneapolis District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 11, 2006 International Brachytherapy s.a. [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Device Reporting/Adulterated N/A *
October 10, 2006 Harry O. Hahn Seafood [ARCHIVED] Philadelphia District Office CGMP for Foods/Seafood HACCP N/A *
October 04, 2006 Dairy Veterinary Services, P.A. [ARCHIVED] New England District Office Illegal Drug Residue N/A *
October 03, 2006 Morgan, Steven J., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
October 02, 2006 Qiagen GmbH [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application Misbranded N/A *
October 02, 2006 Supreme Manufacturing Company, Inc. [ARCHIVED] New Jersey District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded N/A *
October 02, 2006 Ray/Col Inc. [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 01, 2006 Schoenberg, John W. Minneapolis District Office Illegal Drug Residue N/A *
September 28, 2006 Banner Pharmacaps, Inc. [ARCHIVED] Atlanta District Office Drug Manufacturing Operations/CGMP deviations N/A *
September 28, 2006 Wolf, Randall K., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
September 27, 2006 Home Acres Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
September 27, 2006 Hebron International, Inc. [ARCHIVED] Atlanta District Office Device Lacks Marketing Clearance Approval/Adulterated/Misbranded N/A *
September 27, 2006 EP Medsystems [ARCHIVED] New Jersey District Office CGMP Requirements of Medical Device Reporting/Misbranded/Adulterated N/A *
September 27, 2006 Medtronic Vascular [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
September 27, 2006 Softlens Technology [ARCHIVED] Atlanta District Office Device/Lacks Approved Premarket Application/Adulterated/Misbranded N/A *
September 27, 2006 Radiometer Medical Aps [ARCHIVED] Center for Devices and Radiological Health Good Manufacturing Practices / Quality System Regulations N/A *
September 26, 2006 Catso Corp. [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
September 22, 2006 Professional Pad Printing Supply [ARCHIVED] Center for Devices and Radiological Health Performance Standards for Light Emitting Products N/A *
September 22, 2006 Tucson Fruit and Produce [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *

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ICECI Warning Letters

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Food and Drug Administration

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