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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
08/18/2008 Fuji System Corp [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
08/15/2008 Hospital Municipal de San Juan [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) 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 *
08/11/2008 Valley Baptist Medical Center IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
08/11/2008 Hart Dairy II [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
08/08/2008 Lifesoy, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
08/08/2008 Walter's Seafood, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
08/08/2008 DavisMade, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 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 *
08/06/2008 Bruno's of Duluth, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
08/06/2008 Center Oriental Food [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
08/05/2008 Pacific American Fish Co. Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
08/01/2008 Mavidon Medical Products [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/29/2008 NeoChild LLC [ARCHIVED] Dallas District Office CGMP for Medical Devices/QS/Adulterated 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 Schneider, Alan L.,M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
07/23/2008 Simmons Pet Food, Inc. [ARCHIVED] Dallas District Office Deviations From Low Acid Canned Food Regulation/Adulterated N/A *
07/23/2008 Husain, Mustafa M, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
07/22/2008 C.R. Bard, Inc. [ARCHIVED] San Juan District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/18/2008 Tony & Sons Seafood Corp. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
07/17/2008 Washington County Livestock Center, Inc. [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
07/17/2008 Shirk, Clarence W, [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
07/16/2008 ReBuilder Medical Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
07/15/2008 Mesquite Diagnostics [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
07/15/2008 X Spine Systems, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/14/2008 Blue Pacific Seafood, Inc. (DBA Shrimp Works, aka Water Works) [ARCHIVED] Dallas District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
07/14/2008 Schroeder Industries, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/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 Morey's Seafood International, LLC [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
07/08/2008 Brookhaven Memorial Hospital Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
07/08/2008 Dairyland Farm, LLC [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
07/07/2008 Hiroshi's Enterprises, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
07/07/2008 Volk Optical, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated 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 *
06/27/2008 Oncology Tech, LLP [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/27/2008 Pescaderia Atlantica, Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *

 

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ICECI Warning Letters

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