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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
May 01, 2008 Stihler, Alex [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions(Clinical Investigator)/Adulterated N/A *
April 30, 2008 Medical Solutions International, Inc. [ARCHIVED] Kansas City District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 28, 2008 Merck & Company, Inc. [ARCHIVED] Office of Enforcement CGMP Manufacture of Licensed Biological Vaccine Products/Bulk Drug Substances/Components N/A *
April 25, 2008 Stryer Biotech [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 24, 2008 Behavioral Therapeutics, LLC. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
April 23, 2008 Heartsine Technologies, LTD [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
April 23, 2008 Nauta, Haring J.W., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
April 23, 2008 National Biological Corporation [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 23, 2008 Polymer Technologies Systems, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 22, 2008 Sea World, Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
April 22, 2008 Care Rehab and Orthopaedic Products, Inc. [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 21, 2008 Gordon, Stephen W., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
April 21, 2008 Changzhou SPL Company, Ltd ( a/k/a "Kaipu") [ARCHIVED] Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
April 19, 2008 A.B. Cole Dairy Farm [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
April 18, 2008 Classic Catering & Commissary Corp. [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
April 17, 2008 Gemtronics Inc [ARCHIVED] Atlanta District Office New Drug/Labeling/False & Misleading Claims N/A *
April 15, 2008 L. Neil Jones Food Company dba Northwest Packing Company [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
April 15, 2008 Mlsna Dairy Supply, Inc. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
April 15, 2008 Blood Center of New Jersey [ARCHIVED] New Jersey District Office Blood Products/Adulterated N/A *
April 14, 2008 Pal-Nel Farms [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
April 14, 2008 Lynn Medical Instrument Company [ARCHIVED] Detroit District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
April 14, 2008 Torbot Group Inc., Jobskin Division [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 11, 2008 VIBE Technologies, LLC [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 11, 2008 Juices Enterprises Inc. [ARCHIVED] New York District Office Juice HACCP/Adulterated N/A *
April 10, 2008 CNS Response Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded N/A *
April 10, 2008 Don Tray Industries, Ltd [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 09, 2008 John and Maria Nunes Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
April 09, 2008 Simply Fresh Inc. [ARCHIVED] Atlanta District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
April 08, 2008 Pacific Seafood Products, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
April 07, 2008 Asfora, Wilson T. M.D. [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator N/A *
April 04, 2008 D'Ambrosia, Robert D. M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
April 03, 2008 Hato Potrero Farm, Inc [ARCHIVED] Florida District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
April 01, 2008 Philips Medical Systems, Inc [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
April 01, 2008 Supreme Foods Incorporated [ARCHIVED] Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
March 28, 2008 Catalent Pharma Solutions [ARCHIVED] Office of Enforcement CGMP Deviations N/A *
March 28, 2008 Rossmax International Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 26, 2008 Farmacia La Salud Inc. [ARCHIVED] San Juan District Office New Drug/Adulterated/Misbranded/Unapproved N/A *
March 25, 2008 GlaxoSmithKline [ARCHIVED] Atlanta District Office Postmarketing Adverse Drug Experience N/A *
March 25, 2008 Xoran Technologies Inc [ARCHIVED] Detroit District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 25, 2008 Ophthalmic Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
March 21, 2008 Laser Therapeutics, Inc. [ARCHIVED] New England District Office Premarket Approval/Misbranded/Adulterated N/A *
March 21, 2008 CRS Medical Diagnostics, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 20, 2008 Acacia Engineered Products LLC [ARCHIVED] New Orleans District Office CGMP for Medical Devices/Lacks Premarket Approval Application/Adulterated N/A *
March 20, 2008 Brar, Saroj M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 19, 2008 Hoffman, David C. D.D.S. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
March 19, 2008 Shah, Ashok M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 19, 2008 Retro-Tech, LLC [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
March 17, 2008 GMR Products Inc [ARCHIVED] CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 14, 2008 Pyrenees Dairy [ARCHIVED] Los Angeles District Office Illegal Drug Residue N/A *
March 13, 2008 Hilton Becker, MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *

 

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