2009 Warning Letters

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Warning Letters issued in 2009

 

* 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

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 31, 2009	Penumbra, Inc.	San Francisco District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
December 29, 2009	Crothall Healthcare, Inc.	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
December 28, 2009	Branan Medical Corp. Inc.	Los Angeles District Office	Premarket Approval/Misbranded/Adulterated	Not Issued *
December 24, 2009	Micro Current Technology, Inc.	Seattle District Office	Device Lacks Marketing Clearance Approval/Adulterated/Misbranded	Not Issued *
December 23, 2009	Grupo Alimentario Del Atlantico Sa "Gralco Sa"	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
December 23, 2009	Arteriocyte Medical Systems Inc	Center for Biologics Evaluation and Research	Device/Lacks Approved Premarket Application/Adulterated/Misbranded	Not Issued *
December 21, 2009	Paul W. Marks Co., Inc	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
December 21, 2009	Victus, Inc.	Florida District Office	Medical Device/CGMP Requirements of Quality System Regulation	Not Issued *
December 21, 2009	Ohm Laboratories, Inc.	New York District Office	CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
December 17, 2009	Florida Atlantic University IRB	Center for Devices and Radiological Health	Institutional Review Board (IRB)	Not Issued *
December 15, 2009	Sibley Memorial Hospital	Baltimore District Office	CGMP for Blood & Blood Products/Adulterated	Not Issued *
December 15, 2009	Awesome Foods, Inc.	Philadelphia District Office	Food Labeling/Misbranded	Not Issued *
December 15, 2009	Micromed Technology, Inc	Center for Devices and Radiological Health	Medical Device Reporting/Misbranded	Not Issued *
December 14, 2009	Millenkamp Cattle	Seattle District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
December 14, 2009	Chuck's Seafoods, Inc.	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
December 14, 2009	JFD Enterprises Inc	Baltimore District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
December 14, 2009	Burgos Burgos Corp.	Baltimore District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
December 14, 2009	Langit Bali	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
December 14, 2009	Indonesia Clove Cigarettes	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
December 10, 2009	LSG SkyChefs DEN 235	Denver District Office	PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations	Not Issued *
December 09, 2009	Freeman Manufacturing Company Corporation	Detroit District Office	Medical Devices/Adulterated/Misbranded	Not Issued *
December 08, 2009	Kenshin Trading Corporation	Los Angeles District Office	Premarket Approval/Misbranded/Adulterated	Not Issued *
December 07, 2009	MyKretek.com	Center for Tobacco Products	Flavored cigarettes/Misbranded/Adulterated	Not Issued *
December 04, 2009	San Simeon Incorporated	Denver District Office	Seafood HACCP	Not Issued *
December 04, 2009	Nestle USA	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/Misbranded	Not Issued *
December 03, 2009	Ward, John A., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
December 03, 2009	P.M.T. Corp	Minneapolis District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
December 03, 2009	Nestle Healthcare Nutrition	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/Misbranded	Not Issued *
December 01, 2009	www.secretsofbetterhealth.com dba My Cosmetic Company	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
December 01, 2009	Village Cannery Of Vermont, Inc.	New England District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated	Not Issued *
December 01, 2009	Tetracore, Inc.	Baltimore District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
December 01, 2009	Abruzzino's Italian Bakery, LLC	Baltimore District Office	CGMP Manufacturing, Packing, or Holding Human Food/Adulterated	Not Issued *
November 30, 2009	www.bestswinefluvaccine.com	Center for Biologics Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
November 30, 2009	Aregenius Worldwide LLC	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
November 30, 2009	Aluwe, LLC	Minneapolis District Office	Unapproved New Drug/Misbranded	Not Issued *
November 30, 2009	Chaur Fong Inc. dba 888 Food Company	Los Angeles District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
November 30, 2009	Hyde Park Holistic Center	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
November 27, 2009	ICON Clinical Research, Inc.	Center for Drug Evaluation and Research	Bioresearch Monitoring Program	Not Issued *
November 27, 2009	GDMI, Inc	Dallas District Office	CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
November 27, 2009	CFM dba Your Deli	Florida District Office	Seafood/HACCP/CGMP for Foods/Adulterated	Not Issued *
November 24, 2009	Gazda, Thomas M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
November 24, 2009	Buettner, Craig M., MD	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
November 24, 2009	U.F. Union International Food Company	San Francisco District Office	CGMP/Deviations/Adulterated	Not Issued *
November 23, 2009	Quesnel Livestock	New England District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
November 20, 2009	Centra Health Inc Irb	Center for Devices and Radiological Health	Investigational Device Exemptions	Not Issued *
November 20, 2009	Microsulis Medical Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
November 20, 2009	Pan American Laboratories, LLC	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	Not Issued *
November 20, 2009	Wellspring International, Inc.	Minneapolis District Office	Unapproved New Drug	Not Issued *
November 20, 2009	Huaiyin Medical Instruments Co., Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
November 19, 2009	United Fish Distributors, Inc.	Detroit District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *