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
November 03, 2009	Texas Wholesale	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Rokok Zone	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Durango Smoke Shop, Inc.	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Amsterdam Tobacco Co	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	H.J. Bailey Co.	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 03, 2009	Euro-Cigs	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Clove Cigarettes Shop	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Chavez, Inc.	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Heavenly Smoke Inc	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Algisiya Servicesz Limited	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 02, 2009	Li Ning	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 02, 2009	Han, Jeffrey	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 02, 2009	Smoke Shop USA Ltd	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 02, 2009	Lim Sin Wei	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
October 29, 2009	Procter and Gamble	Center for Drug Evaluation and Research	OTC Drug Products/Dietary Supplements/Misbranded	Not Issued *
October 28, 2009	Stew Leonard's Holdings LLC	New England District Office	Food Labeling/False & Misleading Claims/Misbranded	Not Issued *
October 28, 2009	Perry Veterinary Clinic	New York District Office	Extralabel Drug Use in Animals/Adulterated	Not Issued *
October 23, 2009	McKay, Charles M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
October 21, 2009	Minatare Feed Lot Inc	Kansas City District Office	CGMP for Medicated Feeds/Adulterated	Not Issued *
October 16, 2009	Trilogy Crab Co. Inc.	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
October 16, 2009	Schwarz Fish Co.	Minneapolis District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
October 16, 2009	Pacific American Fish Co., Inc	New England District Office	CGMP for Foods/Seafood HACCP/Adulterated	Not Issued *
October 15, 2009	Cold Cut Kruise, Inc.	Detroit District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
October 15, 2009	Weil Lifestyle LLC	Center for Biologics Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus	Not Issued *
October 14, 2009	J & V Dairy, LLC	Seattle District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
October 13, 2009	Cerovene, Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
October 13, 2009	DAVA Pharmaceuticals, Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
October 13, 2009	Myojo USA, Inc.	Los Angeles District Office	Acidified Foods/Emergency Permit Control/Adulterated	Not Issued *
October 13, 2009	Dynamic Surgery, Inc. 10/13/09	New England District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
October 13, 2009	Lehigh Valley Technologies, Inc. 10/13/09	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
October 13, 2009	Glenmark Pharmaceuticals Inc. USA 10/13/09	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
October 09, 2009	Philips Healthcare Inc. 10/9/09	New England District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
October 09, 2009	TLC Laser Eye Centers	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	TLC Laser Eye Center d/b/a TLC Pittsburgh	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LCA Vision Inc	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	TLC Laser Eye Centers	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Evergreen Acres	Minneapolis District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
October 09, 2009	Pacific Nutritional Foods, Inc.	Seattle District Office	Low Acid Canned Food Regulation/Adulterated	Not Issued *
October 09, 2009	LasikPlus Vision Center	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LCA Vision, Inc	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LasikPlus	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LasikPlus Vision Center	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LCA Vision Inc.	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	TLC Laser Eye Centers	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Laser Eye Care of California	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Plus	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *