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 16, 2009	Orion Star & Associates Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Forrest Media Incorporated	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	onlinepharmacyy.com@proxy.dreamhost.com	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Ric Deleon	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Xanos Holdings Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Mendez, Dr Antonio	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Chen-Yu Ou	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Petroff, Andrey	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	tvforever	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	BUZZ, LLC	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	New Horizons LTD	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Krest Holdings, Panama S.A.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Chris Walsh, c/o Dynadot Privacy	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Randek l-warez	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Med Light Ltd	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Lorna Hillier	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Pro West Marketing Ltd.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	William Wynne	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Akyuz, Sinan	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Akyuz, Sinan	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Eugene Lefter	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Hunter, D	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 13, 2009	Everett Laboratories, Inc	New Jersey District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Cornerstone BioPharma, Inc.	Atlanta District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Allegis Pharmaceuticals, LLC	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Larken Laboratories	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Wraser Pharmaceuticals	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Victory Pharma Inc	Los Angeles District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Accentia Biopharmaceuticals, Inc	Florida District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Zyber Pharmaceuticals, Inc	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Tiber Laboratories	Atlanta District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 10, 2009	Arnold Tuber Industries Dba Sci-Dent, Inc	New York District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded	Not Issued *
November 09, 2009	Dallas Jr, Anthony V, MD	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
November 06, 2009	Eisai Medical Research, Inc.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	Not Issued *
November 06, 2009	Dynamic Nutritional Associates	Seattle District Office	Labeling/False & Misleading Claims/Misbranded	Not Issued *
November 03, 2009	Gibson Laboratories Inc	Cincinnati District Office	CGMP for Medical Devices/QS/Adulterated	Not Issued *
November 03, 2009	Durango Smoke Shop, Inc.	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Euro-Cigs	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	Amsterdam Tobacco Co	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 03, 2009	Texas Wholesale	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	Heavenly Smoke Inc	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	Rokok Zone	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 02, 2009	Smoke Shop USA Ltd	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	Li Ning	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 *