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Warning Letters 2006

2006 Warning Letters and Untitled Letters to Pharmaceutical Companies 

These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning 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. Click on the links in each month to view the letters in Adobe Acrobat format. [more...]

December 2006
Product/IssueCompany/IndividualDivisionReleasedPosted

Dyrenium (triamterene) capsules

WellSpringDDMAC12/19/20061/9/2007

November 2006
Product/IssueCompany/IndividualDivisionReleasedPosted

Seroquel

AstraZenecaDDMAC11/16/200611/20/2006
Clinical Investigator
(Warning Letter)
 
Dr. Philip B. SchworerDSI11/7/200611/7/2006

October 2006
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)E. Clinton Lawrence, MDDSI11/16/20064/15/2008

Maxair Autohaler (pirbuterol acetate inhalation aerosol) (Warning Letter)

3M Corporate HeadquartersDDMAC10/19/200610/20/2006

MD-GASTROVIEW (Warning Letter)

Mallinckrodt Inc.DDMAC10/13/200610/18/2006

Nevanac (nepafenac ophthalmic suspension) (Warning Letter)

Alcon, Inc.DDMAC10/20/200610/20/2006

ONTAK (denileukin diftitox) and Targretin (bexarotene) capsules (Warning Letter)

Ligand Pharmaceuticals, Inc.DDMAC10/23/200610/25/2006

Orapred (prednisolone sodium phosphate oral solution) (Warning Letter)

BioMarin Pharmaceutical Inc.DDMAC10/11/200610/11/2006

September 2006
Product/IssueCompany/IndividualDivisionReleasedPosted
Clinical Investigator (Warning Letter)Herman Zaharowitz, M.D.DSI9/14/20069/26/2006

VoSpire ERQì (albuterol sulfate) Extended-Release Tablets (Warning Letter)

DAVA Pharmaceuticals, Inc.DDMAC9/21/20069/21/2006

Rythmol SR (propafenone HCl)extended release Capsules (Warning Letter)

Reliant Pharmaceuticals, Inc.DDMAC9/14/20069/15/2006

August 2006
Product/IssueCompany/IndividualDivisionReleasedPosted
BIMO inspectionMDS PharmaCompliance8/31/20069/11/2006
Clinical Investigator (Warning Letter)Professor Olga D. OstroumovaDSI8/18/200610/5/2006

Prograf (tacrolimus capsules and injection) (Warning Letter)

Astellas Pharma US, Inc.DDMAC8/31/20069/5/2006

 
July 2006
Product/IssueCompany/IndividualDivisionReleasedPosted

Alimta (pemetrexed) for injectio

Eli Lilly and CompanyDDMAC7/27/20067/31/2006
Clinical Investigator (Warning Letter)Evangeline G. Gonzalez, M.D.DSI7/6/20068/10/2006

June 2006
Product/IssueCompany/IndividualDivisionReleasedPosted

Zovirax (acyclovir) Ointment (Warning Letter)

GlaxoSmithKlineDDMAC6/30/20066/30/2006

Hydase (hyaluronidase Injection) (Warning Letter)

PrimaPharm, Inc.DDMAC6/29/20066/30/2006
Sponsor-Applicant-Monitor-Clinical Research Organization (Warning Letter)Cell PointDSI6/15/20067/21/2006
Clinical Investigator (Warning Letter)Massimo Cristofanilli, M.D.DSI6/15/20067/21/2006
Institutional Review Board (Warning Letter)MD Anderson Cancer CenterDSI6/15/20067/21/2006
Site Inspection (Warning Letter)RanbaxyDMPQ6/15/20066/23/2006

May 2006
Product/IssueCompany/IndividualDivisionReleasedPosted
GLP for non-clinical laboratory studies (Warning Letter)North American Science Associates, Inc.DSI5/11/20065/22/2006

Bupropion hydrochloride extended-release tablets (SR)

SandozDDMAC5/26/20065/30/2006

Spiriva Handihaler

Boehringer Ingelheim PharmaceuticalsDDMAC5/25/20065/25/2006

April 2006
Product/IssueCompany/IndividualDivisionReleasedPosted
Site Inspection (Warning Letter)Pliva Croatia Ltd.Compliance4/28/20065/5/2006

Sotradecol (sodium tetradecyl sulfate injection) (Warning Letter)

Bioniche Pharma Group LimitedDDMAC4/4/20064/18/2006

March 2006
Product/IssueCompany/IndividualDivisionReleasedPosted
Site Inspection (Warning Letter)Wockhardh, Ltd.DMPQ2/21/20064/10/2006

Infergen

InterMune, Inc.DDMAC3/28/20064/3/2006

February 2006
Product/IssueCompany/IndividualDivisionReleasedPosted

M.V.I.-12 (Multi-Vitamin Infusion without Vitamin K) (Warning Letter)

Mayne Pharma (USA)DDMAC2/12/20063/8/2006

(NeutroSpec Kit for the Preparation of Technetium (99m Tc fanolesomab)

Palatin TechnologiesDDMAC2/16/20063/3/2006

January 2006
Product/IssueCompany/IndividualDivisionReleasedPosted

Benicar (olmesartan) Warning Letter

Sankyo Pharma, Inc.DDMAC1/6/20061/11/2006

Cenestin (snythetic conjugated estrogens, A) (Warning Letter)

DuramedDDMAC1/4/20061/18/2006
Institutional Review Board (Warning Letter)Human Investigation Committee of Houston, TexasDSI1/23/20061/30/2006

Loprox Shampoo (ciclopirox)

Medicis PharmaceuticalDDMAC1/420061/11/2006

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