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U.S. Department of Health and Human Services

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2008 Warning Letters

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Warning Letters issued in 2008

 

* 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
09/02/2008 Jerusalem Manufacturing Nature Foods & Wholesalers, Inc. [ARCHIVED] Detroit District Office Food Labeling/False & Misleading Claims/Adulterated/Misbranded N/A *
09/01/2008 Concept Laboratories, Inc. [ARCHIVED] Chicago District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
08/29/2008 KeraCure, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
08/29/2008 VL Livestock Company, Inc. [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
08/25/2008 Ovation Pharmaceuticals, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/False & Misleading/Misbranded N/A *
08/22/2008 Health Center for Better Living, Inc. [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims N/A *
08/21/2008 Brede, Inc. [ARCHIVED] Detroit District Office CGMP/Deviations For Food Manufacturers/Adulterated N/A *
08/21/2008 SeniorLife Health Inc. [ARCHIVED] Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
08/20/2008 Suarez Corporation Industries, Inc. [ARCHIVED] Cincinnati District Office Premarket Approval/Misbranded/Adulterated N/A *
08/19/2008 ONBO Electronics Company Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
08/19/2008 AliMed Corporation [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
08/15/2008 Daniel Chapter One Inc [ARCHIVED] New England District Office New Drug/Labeling/False & Misleading Claims N/A *
08/14/2008 Prismic Light International, aka Sandent Co. [ARCHIVED] New Orleans District Office Dietary Supplement/Labeling/Misbranded N/A *
08/12/2008 GE Healthcare Integrated IT Solution [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
08/12/2008 Sandoz Inc. [ARCHIVED] Atlanta District Office CGMP/Deviations/Adulterated N/A *
08/12/2008 Capitol Cake Co. [ARCHIVED] Baltimore District Office CGMP Regulation For Food/Adulterated N/A *
08/12/2008 Mallinckrodt Inc., dba Covidien [ARCHIVED] Kansas City District Office CGMP/Deviations/Adulterated N/A *
08/08/2008 Lifesoy, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
08/07/2008 Gaunitz Hair Sciences, LLC [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded N/A *
08/07/2008 Sunetics International Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded N/A *
08/06/2008 Cascadia Manufacturing, Inc. [ARCHIVED] Seattle District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated N/A *
08/06/2008 O'Ryan Industries, Inc. [ARCHIVED] Seattle District Office Device Lacks Marketing Clearance Approval/Adulterated/Misbranded N/A *
07/29/2008 LifeGuard Health LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Promotional Claims False & Misleading/New Drugs N/A *
07/24/2008 G & W Laboratories, Inc. [ARCHIVED] CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
07/23/2008 Simmons Pet Food, Inc. [ARCHIVED] Dallas District Office Deviations From Low Acid Canned Food Regulation/Adulterated N/A *
07/22/2008 C.R. Bard, Inc. [ARCHIVED] San Juan District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/16/2008 ReBuilder Medical Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
07/10/2008 Baker's Breakfast Cookie, Inc. [ARCHIVED] Seattle District Office Food Labeling/False & Misleading Claims/Misbranded N/A *
07/09/2008 Sharp Labs Inc [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims N/A *
07/09/2008 Tattva's Herbs, LLC [ARCHIVED] Seattle District Office Promotional Claims False & Misleading/Misbranded N/A *
07/08/2008 Dairyland Farm, LLC [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
07/03/2008 Carematrix, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/02/2008 Full Circle Dairy, LLC [ARCHIVED] Florida District Office Illegal Drug Residue N/A *
07/02/2008 Anika Therapeutics, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/30/2008 Travanti Pharma, Inc. [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
06/25/2008 Cargill, Inc. [ARCHIVED] Seattle District Office CGMP for Medicated Feeds/Adulterated N/A *
06/24/2008 Newman Inc., (dba Medi-Stat) [ARCHIVED] New Orleans District Office New Drug/Adulterated/Misbranded N/A *
06/20/2008 Synapse Biomedical Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
06/16/2008 HoMedics, Incorporated [ARCHIVED] Detroit District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
06/10/2008 Hontech Foundation for Medical Technology [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/04/2008 Kimberly-Clark Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting N/A *
06/04/2008 A.P. Bell Fish Company, Inc. [ARCHIVED] Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
06/03/2008 Vitasalus, Inc. [ARCHIVED] Detroit District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
06/03/2008 LeMaitre Vascular [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
06/03/2008 Nutrition 2000 [ARCHIVED] New Orleans District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
06/02/2008 NaturesAlternatives.com [ARCHIVED] Los Angeles District Office Promotional Claims/False & Misleading N/A *
06/02/2008 Institute for Healthy Aging [ARCHIVED] Florida District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
06/02/2008 Fem Health [ARCHIVED] Atlanta District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
06/02/2008 Rayong Fish Sauce Industry Co., Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
06/02/2008 Hamlin, Charles M.D. [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator N/A *

 

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