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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
06/08/2009 Health Food Emporium [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/08/2009 North Valley Veterinary Clinic, Inc. [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
06/05/2009 Nature's Sunshine Products Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/05/2009 Frantz Design, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Medical Device Reporting/Misbranded N/A *
06/05/2009 The South Bend Chocolate Company, Inc. [ARCHIVED] Detroit District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
06/05/2009 ffrench Pocket Airway, Inc. [ARCHIVED] New Orleans District Office Investigational Device Exemptions N/A *
06/04/2009 UVHealth Direct, LLC [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/04/2009 American Ultraviolet Co. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/04/2009 Seacoast Natural Foods, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/02/2009 Circular Enterprises, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/02/2009 Field Controls, LLC [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/02/2009 InspiredLiving.com [ARCHIVED] Seattle District Office New Drugs, Unapproved/Labeling/Misbranded N/A *
06/02/2009 Pet Kiss Inc. [ARCHIVED] Los Angeles District Office New Animal Drug Application N/A *
06/02/2009 Atrium Innovation Limited [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/02/2009 Coberg, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated N/A *
06/01/2009 Medtronic Puerto Rico Operations Company [ARCHIVED] San Juan District Office CGMP/QSR/Medical Devices/Adulterated N/A *
05/29/2009 Simple Clinic, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/29/2009 Bioset [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/29/2009 Fitura, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/29/2009 Won Feng Trading Inc [ARCHIVED] New Orleans District Office CGMP Regulation For Food/Adulterated N/A *
05/29/2009 Performance Brand Flucinex [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/29/2009 Boles Livestock [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
05/29/2009 UltraRad Corporation [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
05/29/2009 Reynolds, Newton J. [ARCHIVED] New England District Office Illegal Drug Residue N/A *
05/28/2009 Amrita Aromatherapy, Inc [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/28/2009 Inhalation Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/28/2009 Opportunity Dairy [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
05/27/2009 R P Gomes, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated N/A *
05/27/2009 Union Springs Pharmaceuticals [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/26/2009 Guilin Hospital of Sino-western Medicine [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/22/2009 Crystal Care International Inc [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
05/22/2009 Nozin LLC [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/22/2009 H & H Products Company [ARCHIVED] Florida District Office Juice HACCP/Adulterated N/A *
05/21/2009 Chi Machine International [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
05/21/2009 Sitek Research Laboratories [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
05/21/2009 Southern Foods Group, LLC [ARCHIVED] Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
05/20/2009 Richard E. Ringel, M.D. [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator N/A *
05/20/2009 Rocky Mountain Environmental [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/20/2009 Feins, Neil R., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
05/20/2009 Water and Power Technologies, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Adulterated N/A *
05/20/2009 Xttrium Laboratories, Inc. [ARCHIVED] Chicago District Office Drug Manufacturing Operations/CGMP deviations N/A *
05/19/2009 Jes-Made Bakery [ARCHIVED] Philadelphia District Office Labeling N/A *
05/19/2009 GlycoMeds, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/19/2009 Perelandra, LTD [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/19/2009 Nature's Health Supply [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/19/2009 Carters Milk Factory [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
05/19/2009 Wellness Resources, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/19/2009 Hijazi, Saad, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
05/18/2009 NZYMES.COM [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
05/18/2009 Storz Endoskop GMBH [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *

 

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ICECI Warning Letters

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Food and Drug Administration

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