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

Posted on April 08, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
January 25, 2008	Clasen Quality Coatings, Inc.	Minneapolis District Office	CGMP Deviations	N/A *
January 24, 2008	Medical Action Industries	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
January 24, 2008	Alfa International Seafood, Inc. & Gamma Seafood Corporation	Florida District Office	Seafood HACCP	N/A *
January 24, 2008	Novartis Vaccines and Diagnostics	Center for Biologics Evaluation and Research	CGMP Deviations	N/A *
January 23, 2008	Diagnostic Health Center of Texas, L.P.	Dallas District Office	Mammography Quality Standards Act	N/A *
January 23, 2008	Adams, Mark M.D.	Center for Devices and Radiological Health	Investigational Device Exemptions	N/A *
January 22, 2008	Glen Willow Orchards	Philadelphia District Office	Juice HACCP	N/A *
January 18, 2008	OLMA-XXI Inc	New York District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
January 18, 2008	Replidyne, Inc.	Center for Drug Evaluation and Research	Sponsor-Applicant-Monitor-Clinical Research Organization	N/A *
January 18, 2008	Replidyne, Inc.	Center for Drug Evaluation and Research	Sponsor-Applicant-Monitor-Clinical Research Organization	N/A *
January 18, 2008	Omron Healthcare, Inc.	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
January 17, 2008	Lyne Laboratories, Inc.	New England District Office	CGMP for Finished Pharmaceuticals/Adulterated	N/A *
January 16, 2008	Old Carolina Farms	Baltimore District Office	Illegal Drug Residue	N/A *
January 15, 2008	Piedmont Dairy	Atlanta District Office	Illegal Drug Residue	N/A *
January 15, 2008	Hill-Rom, Inc.	Detroit District Office	CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded	N/A *
January 14, 2008	Tomita Pharmaceutical Co., Ltd	Center for Drug Evaluation and Research	CGMP/Active Pharmaceutical Ingredients/Adulterated	N/A *
January 14, 2008	Bellevue Pharmacy Solution	Kansas City District Office	Promotional Claims False & Misleading/Misbranded	N/A *
January 14, 2008	Baxa Corporation	Denver District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
January 11, 2008	Papas Dairy, LLC	New York District Office	Illegal Drug Residue	N/A *
January 10, 2008	American Hormones, Inc.	New York District Office	New Drug/Adulterated/Misbranded	N/A *
January 09, 2008	Land Ice and Fish Limited	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated	N/A *
January 09, 2008	Trinidad Dock & Fishing Services Ltd	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
January 09, 2008	Rai, Ansaar T., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
January 08, 2008	Wilbur Ellis Company	Seattle District Office	CGMP for Medicated Feeds/Adulterated	N/A *
January 07, 2008	Saint John's Medical Plaza Pharmacy	Los Angeles District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 07, 2008	Panorama Compounding Pharmacy	Los Angeles District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 07, 2008	Reed's Compounding Pharmacy	Los Angeles District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 07, 2008	Pharmacy Compounding Specialties	Dallas District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 07, 2008	Global Protection Corp.	New England District Office	CGMP/QSR/Medical Device Reporting/Adulterated	N/A *
January 07, 2008	Delicias de Espana, Inc.	Florida District Office	Seafood HACCP/Insanitary Conditions/Adulterated	N/A *
January 07, 2008	Pacifica Pharmacy	Los Angeles District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 07, 2008	Village Compounding Pharmacy	Dallas District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 07, 2008	Murray Avenue Apothecary	Philadelphia District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
January 04, 2008	Noven Pharmaceuticals, Inc.	Florida District Office	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated	N/A *
January 03, 2008	Amico Laboratories, Inc.	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
January 03, 2008	Care Tech Industries, Inc.	Florida District Office	Premarket Approval/Misbranded/Adulterated	N/A *
January 03, 2008	Superior Products, Inc.	Cincinnati District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
January 03, 2008	ConnexMD, Inc.	Seattle District Office	CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded	N/A *

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