Warning Letters 2013

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER Headquarters Warning Letters.

Office of Prescription Drug Promotion Letters (formerly Division of Drug Marketing, Advertising, and Communications)

Office of Compliance/Immediate Office

Office of Drug Security, Integrity and Recalls

Office of Manufacturing and Product Quality Letters

Office of Scientific Investigations Letters

For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857
Instructions for how to submit an FOI request can be found on the FDA FOI Page.

Office of Prescription Drug Promotion

Company/Individual	Product/Issue	Issue Date
CBA Research, Inc. Untitled Letter (PDF - 236KB) Promotional Material (PDF - 1.2MB)	CBT-1 (tetrandrine) Capsule	4/25/13
Teva Neuroscience, Inc. Untitled Letter (PDF - 74KB) Promotional Material (PDF - 588KB)	ANDA 076809 Clozapine Tablets USP	4/8/13
Photocure ASA c/o Cato Westpark Corporate Center Untitled Letter (PDF - 85KB) Promotional Material (PDF - 792KB)	NDA 022555 Cysview (hexaminolevulinate hydrochloride), for Intravesical Solution	3/4/13
ParaPRO, LLC Untitled Letter (PDF - 58KB)	NDA 022408 Natroba (spinosad) topical suspension, 0.9%	2/21/13
Alcon Research Ltd. Untitled Letter (PDF - 77KB) Promotional Material (PDF - 617KB)	NDA 021545 Pataday (olopatadine hydrochloride ophthalmic solution) 0.2%	2/5/13

Office of Compliance/Immediate Office

Company/Individual	Product/Issue	Issue Date
Medsnoscript (WARNING LETTER)	Internet Marketing of unapproved drug (Generic Tamiflu) on www.Medsnoscript.com	2/11/13
Secure Medical Inc. (WARNING LETTER)	Internet Marketing of unapproved drug (Tamiflu 75mg Gel Tablet) on www.viamedic.com, www.accessrx.com, and www.AmeriMedixRx.com	2/11/13
Sun Drug Store (WARNING LETTER)	Internet Marketing of unapproved drug (Generic Tamiflu) on www.SunDrugStore.com	2/11/13
Discount Online Pharmacy (WARNING LETTER)	Internet Marketing of unapproved drug (Generic Tamiflu) on www.topsavingspharmacy.com	2/11/13
Oasis Consumer Healthcare, LLC (WARNING LETTER)	Internet Marketing of unapproved drug (Halo) on www.halogermdefense.com	2/11/13
buy-pharma.com(WARNING LETTER)	Internet Marketing of unapproved drug (Pirfenidone) on www.buy-pharma.com, on January 8, 2013	2/4/13
Big Mountain Drugs (WARNING LETTER)	Internet Marketing of unapproved drug (Pirfenidone) on www.bigmountaindrugs.com, and www.buypirfenidone.com, on October 24, 2012 and October 26, 2012, respectively, and websites www.bestbuyrx.com and www.drugworldcanada.com on January 8, 2013	2/4/13
Flu and Cold Defense LLC (WARNING LETTER)	False and misleading statements; Internet marketing of product GermBullet on www.germbullet.com and www.nsaroma.com	1/24/13

Office of Drug Security, Integrity and Recalls

Company/Individual	Product/Issue	Issue Date

Office of Manufacturing and Product Quality

Company/Individual	Product/Issue	Issue Date
Kanebo Cosmetics, Inc. (WARNING LETTER)	regulations for finished pharmaceuticals	4/1/13
Wyeth Lederle S.p.A. (WARNING LETTER)	regulations for finished pharmaceuticals	3/27/13
Peking Medicine Manufactory (WARNING LETTER)	regulations for finished pharmaceuticals	3/25/13
Asada Milling Co., Ltd (WARNING LETTER)	manufacture of APIs	3/22/13
Apotex, Inc. (WARNING LETTER)	regulations for finished pharmaceuticals	2/21/13
P.A. Benjamin Manufacturing Co., Ltd. (WARNING LETTER)	regulations for finished pharmaceuticals	1/29/13
Jubilant HollisterStier General Partnership (WARNING LETTER)	regulations for finished pharmaceuticals	2/20/13