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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
June 25, 2008 Cargill, Inc. [ARCHIVED] Seattle District Office CGMP for Medicated Feeds/Adulterated N/A *
June 25, 2008 Encore Medical, L.P. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 25, 2008 IOPI Northwest Company, LLC [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 25, 2008 Sauflon Pharmaceuticals, LTD [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting N/A *
June 25, 2008 I.T. Foods Industries Co., LTD. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 24, 2008 Newman Inc., (dba Medi-Stat) [ARCHIVED] New Orleans District Office New Drug/Adulterated/Misbranded N/A *
June 23, 2008 Mathis Ranch, LLC dba Texas Legend Ranch [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 20, 2008 KeyMed (Medical and Industrial Equipment) Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
June 20, 2008 Synapse Biomedical Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
June 20, 2008 J & S Dairy Farm Inc. [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 19, 2008 Emerson Seafood, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 19, 2008 Uintah Basin Medical Center [ARCHIVED] Denver District Office CGMP for Blood & Blood Components/Adulterated N/A *
June 19, 2008 Domina, Gary [ARCHIVED] New England District Office Illegal Drug Residue N/A *
June 19, 2008 Captain Jackie's Seafood, Inc. [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 17, 2008 Nick & Katie's Inc. [ARCHIVED] New Orleans District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
June 16, 2008 HoMedics, Incorporated [ARCHIVED] Detroit District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
June 13, 2008 Green's Fresh Fruit Salad Corporation (dba Salad Chef) [ARCHIVED] Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 11, 2008 T.H. Seafood [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 11, 2008 Duro-Med Industries [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 11, 2008 Ipswich Shellfish Co., Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 10, 2008 Hazenberg Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
June 10, 2008 Hontech Foundation for Medical Technology [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 10, 2008 Reproductive Medicine & Fertility Center of Southern Colorado LLC [ARCHIVED] Denver District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
June 09, 2008 New Sun, Inc. [ARCHIVED] Atlanta District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 09, 2008 Nutritional Counselors of America [ARCHIVED] New Orleans District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 09, 2008 Harris Dairies [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 06, 2008 Ponugoti, Nagarjuna R., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
June 06, 2008 Chattem, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
June 05, 2008 Miller's Bakery, inc. [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded N/A *
June 04, 2008 Kimberly-Clark Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting N/A *
June 04, 2008 A.P. Bell Fish Company, Inc. [ARCHIVED] Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
June 03, 2008 Vitasalus, Inc. [ARCHIVED] Detroit District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 03, 2008 Grimm's Stone Crab Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 03, 2008 LeMaitre Vascular [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
June 03, 2008 Seoul Shopping, Inc [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
June 03, 2008 Sysco Food Services of Albany, LLC [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 03, 2008 Sysco Food Services of Albany, LLC [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 03, 2008 Nutrition 2000 [ARCHIVED] New Orleans District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 02, 2008 NaturesAlternatives.com [ARCHIVED] Los Angeles District Office Promotional Claims/False & Misleading N/A *
June 02, 2008 Institute for Healthy Aging [ARCHIVED] Florida District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 02, 2008 Fem Health [ARCHIVED] Atlanta District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 02, 2008 Rayong Fish Sauce Industry Co., Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 02, 2008 Hamlin, Charles M.D. [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator N/A *
June 02, 2008 Dherbs.com [ARCHIVED] Los Angeles District Office New Drug/Labeling/False Promotional Statements/Misbranded N/A *
May 30, 2008 Hsueh, Willa A., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
May 30, 2008 Sandstone Medical Technologiess, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
May 29, 2008 Cheyenne Dairy No. 2 [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
May 29, 2008 Road to Healing [ARCHIVED] New Orleans District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 28, 2008 Corces, Arturo, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
May 28, 2008 Alliance Dairies [ARCHIVED] Florida District Office Illegal Drug Residue N/A *

 

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