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Warning Letters 2009


2009 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 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

NDA 21-225
Mirena® (levonorgestrel-releasing intrauterine system)

Bayer HealthCare Pharmaceuticals Inc.Division of Drug Marketing,
Advertising, and Communications
12/30/091/12/10

NDA 21-773, 21-919
Byetta® (exenatide) injection

Amylin Pharmaceuticals, Inc.Division of Drug Marketing,
Advertising, and Communications
12/24/091/12/10

NDA # 22-249, NDA # 22-303 Treanda® (bendamustine hydrochloride) for Injection

Cephalon, Inc.Division of Drug Marketing,
Advertising, and Communications
12/18/091/12/10

Clinical Investigator

John A. Ward, M.D.Division of Scientific Investigations12/3/0912/22/09
November 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Sponsor-Applicant-Monitor-Clinical Research Organization

ICON Clinical ResearchDivision of Scientific Investigations11/27/0912/8/09

Clinical Investigator

Craig M. Buettner, M.D.Division of Scientific Investigations11/24/0912/15/09

Clinical Investigator

Thomas Gazda, M.D.Division of Scientific Investigations11/24/091/12/10

NDA 18-332
INDOCIN® (indomethacin) ORAL SUSPENSION

Iroko Pharmaceuticals, LLCDivision of Drug Marketing,
Advertising, and Communications
11/17/0911/20/09

Internet Marketing of Unapproved and Misbranded Drugs

Chen-Yu Ou 

(366rx.com, rxabode.com, and rxcart.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

I-warez Randek

(thewomantour.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Dr. Antonio Mendez

(uk-online-pharmacy.com and online-pharmacy-4u.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Forrest Media Incorporated

(approved-swiss-meds.com, 

buy-rx-today.com, direct-rx-refill.com, value-european-pharmacy.com, mypillsfinder.com, dutyfreemeds.com, swissmeds.com, bestrxdeal.com, 

happypharmacy.net and 

european-pharm.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Orion Star & Associates, Inc.
(i-want-rx.com, refill-online.com, ultra-rx.com, trust-pharm.com, trust-european-pharmacy.com, pill-planet.com, and pharmacy-usa.biz)
Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Lorna Hillier

(buyonlinemedications.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Pro West Marketing Ltd

(doctorphentermine.com, trusted-tabs.us, online-pharmacy-no-prescription.com, 365pharm.com, approved-pharm.com, value-drugstore.com, cheapphentermine.com, rx-giant.com, 4cheaprx.com, preferredpharma.com, prescriptionsintl.com, aprixe.com, buycanadianpharmacy.net, terameds.org, dragon-rx.com, first-refill-c1ub.com, bestrxpharm.net, pharma-direct.com, buy-canadian-pharm.com, easy-pharm.com, licensed-medical.com, my-refilldrugstore. com, refill-rx-now.com, rxcalm.com, top-hotpills.com, top-uspharm.com, my-pill.com, smsrx.net, total-pharma.com, pharma-discounts.com, and rxontv.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Buzz net - BUZZ LLC

(cheap-phentermine-online.net)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Andrey Petroff

(shrinkrapthemovie.com, bikekmba.org, dinnerdvrsLcom, myfleacircus.com, petpetcentral.com, sorasheart.com, and walona.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Sinan Akyuz

(onlinepharmacynorx.info)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Michael Trinidad - tvforever

(michaelpharmacy.com, mywebmarquee.com, pharmazero.com, and pharmalove.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

D Hunter

(medspricedright.com and valuedrugspharmacy.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Sinan Akyuz

(goask.org)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Chris Walsh c/o Dynadot Privacy

 

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Xanos Holdings Inc.

(direct-pharm.com, us-value-pharm.com, global-drugstore.com, refill-club.com, global-generics-source.com, european-drugstore.com, first-canadian-pharm.com, mexican-pharm.com, pillsshipping.com, rxgenericsstore.com, americanmedsdirect.com, and usrxmeds.net)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Krest Holdings

(approved-swiss-drugstore.com, swiss-meds.com, approved-refill-club.com, first-refill-online.com, rxpharm.ws, global-rx-pharm.com, refill-drugstore.com, generics-pharm.net, mediwax.com, discountwebmeds.com, approved-medical.com, allgenericpills.com, rxbynet.com, and pricedpills.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

onlinepharmacyy.comOffice of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Med Light LTD

(refill-rxmeds.com, brand-meds.com, buy-american-pharma.com, online-pharma-rx.com, rx-easypharmacy.com, first-american-pharmacy.com, brand-pharma.com, secure-rx-refills.com, american-pharm.com, first-swiss-meds.com, rx-life.com, quickgeneric.com, us-pharmacy.us, epharmacy-usa.com, and medscourier.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Ric Deleon

(247meds.com, 24-7pills.com, 24-7rx.com, and bestdealrx.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

New Horizons LTD

(topdrugstore.net, us-rx-meds.com, first-swiss-pharm.com, first-swiss-pharmacy.com, mexicanpharma.com, central-rx-refill.com, cheapdrugsmd.com, pharmacytouch.com, lion-rx.com, mypillshop.net, american-pharma.com, approved-swiss-pharm.com, approved-swisspharma.com, approved-swiss-pharmacy.com, and first-swiss-drugstore.com)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs 

William Wynne

(andersenpharmacy.com and dukepharmacy.com?)

Office of Compliance11/16/0911/19/09

Internet Marketing of Unapproved and Misbranded Drugs

Eugene Lefter 

(wellknowndrugs.com)

Office of Compliance11/16/0911/19/09

Clinical Investigator

Anthony Dallas, M.D.      Division of Scientific Investigations11/9/0911/17/09

Dacogen® (decitabine)

Eisai, Inc.Division of Drug Marketing,
Advertising, and Communications
11/6/0911/13/09

Fosrenol® (lanthanum carbonate hydrate) Chewable Tablets

Shire Development IncDivision of Drug Marketing,
Advertising, and Communications
11/5/0911/13/09

H1N1 Flu Virus-Related Products

Silver Soft for SkinOffice of Compliance11/4/094/23/10

 

 

October 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C

Procter and GambleOffice of Compliance10/29/0910/30/09

NDA # 21-287
UROXATRAL® (alfuzosin HCl) Extended-Release Tablets for Oral use

Sanofi-Aventis U.S. LLCDivision of Drug Marketing,
Advertising, and Communications
10/23/0910/27/09

Clinical Investigator

Charles McKay, MDDivision of Scientific Investigations10/23/0911/13/09

Institutional Review Board

MI Hope Inc. dba Center for Complex Infectious DiseasesDivision of Scientific Investigations10/19/0912/29/09
  • NDA 22-321
    EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use
King Pharmaceuticals, Inc.Division of Drug Marketing,
Advertising, and Communications
10/8/0910/22/09

Codeine Sulfate Tablets, 30 mg & 60 mg

Cerovene, Inc.Division of New Drugs and Labeling Compliance10/13/0910/13/09

Codeine Sulfate Tablets, 30 mg

Warning Letter

Dava International, Inc.Division of New Drugs and Labeling Compliance10/13/0910/13/09

Codeine Sulfate Tablets, 30 mg & 60 mg

Glenmark Generics, Inc.Division of New Drugs and Labeling Compliance10/13/0910/13/09

Codeine Sulfate Tablets, 30 mg & 60 mg

Warning Letter

Lehigh Valley Technologies, Inc.Division of New Drugs and Labeling Compliance10/13/0910/13/09

Institutional Review Board

Burzynski Research Institute IRB
 
Division of Scientific Investigations10/5/0912/8/09

 

 

September 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus

Warning Letter

SKW VenturesOffice of Compliance9/14/0910/22/09

Viraban Hand Sanitizers; Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus

Warning Letter

Kevin Lilly

 

Office of Compliance9/14/0910/22/09

ANDA #40-541 Sotradecol™ (sodium tetradecyl sulfate injection)

Bioniche PharmaDivision of Drug Marketing,
Advertising, and Communications
9/14/099/16/09

NDA #22-369 LatisseTM (bimatoprost ophthalmic solution) 0.03%

Allergan, Inc.Division of Drug Marketing,
Advertising, and Communications
9/10/099/16/09

 

August 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Sodium Tetradecyl Sulfate (STS) Injection, 2%, 4% and 5%

Warning Letter

Hopewell Pharmacy and
Compounding Center aka Drugs Are Us, Inc
Division of New Drugs and Labeling Compliance
 
8/28/0911/13/09

API Manufacturing

Warning Letter

 

Sumitomo Chemical Company LimitedDivision of Manufacturing and Product Quality8/24/0910/13/09

ERTACZO™ (sertaconazole nitrate) Cream, 2%

(Warning Letter)

Johnson & Johnson, Consumer & Personal Products WorldwideDivision of Drug Marketing,
Advertising, and Communications
8/21/098/25/09

Nalfon® (fenoprofen calcium capsules) 200 mg and 400 mg

(Warning Letter)

Pedinol Pharmacal, Inc.Division of Drug Marketing,
Advertising, and Communications

8/20/09

 

8/25/09

Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%)

(Warning Letter)

Galderma LaboratoriesDivision of Drug Marketing,
Advertising, and Communications
8/18/098/21/09

Tri-Luma Cream (fluocinolone acetonide 0.01 %; hydroquinone 4%; tretinoin 0.05%), NDA 21-112

(Warning Letter)

Hill Dermaceuticals, Inc.
 
Division of New Drugs and Labeling Compliance8/18/099/16/09

ACZONE® (dapsone) Gel, 5% 

(Warning Letter)

Allergan, Inc.Division of Drug Marketing,
Advertising, and Communications
8/17/098/21/09

Manufacture of APIs

(Warning Letter)

Cambrex Profarmaco MilanoDivision of Manufacturing and Product Quality8/12/099/16/09

Sponsor-Applicant-Monitor-Clinical Research Organization

(Warning Letter)

 

Karen Grosser, Ph.D, MBA, Johnson & Johnson Pharmaceutical Research & Development IRBDivision of Scientific Investigations8/10/098/21/09

Manufacture of non-sterile APIs

(Warning Letter)

Bayer HealthCareDivision of Manufacturing and Product Quality8/5/099/16/09

 

July 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Institutional Review Board
(Untitled Letter)

CHRISTUS Schumpert Health System IRBDivision of Scientific Investigations7/30/098/21/09

Clinical Investigator

(Warning Letter)

 

Barbara A. Harris, Ph.D.
 
Division of Scientific Investigations7/27/098/21/09

CGMP/Adulterated

(Warning Letter)

Antibioticos do Brasil Uda.Division of Manufacturing and Product Quality7/24/098/21/09

H1N1 Flu Virus- Related Products

Warning Letter

TcmhelpmeOffice of Compliance7/22/0910/22/09
Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus
(Warning Letter)
Q-Based Solutions, Inc.Office of Compliance7/22/097/27/09

All Soapopular hand sanitizers

(Warning Letter)

 

MGS RepresentationsOffice of Compliance7/15/097/23/09

NDA #s 21-226; 21-251; & 21-906 Kaletra® (lopinavir & ritonavir) Tablets, Oral Solution, and Capsules

(Warning Letter)

 

Abbott LaboratoriesDivision of Drug Marketing, Advertising, and Communications7/14/097/22/09

NDA #19-618 Rowasa® (mesalamine) Rectal Suspension Enema
(Warning Letter)

 

Alaven Pharmaceutical LLCDivision of Drug Marketing, Advertising, and Communications7/13/097/22/09

 

June 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Non-sterile oral solid dosage drug products(Warning Letter) 

PDF

HTML

 

Apotex, Inc.Division of Manufacturing and Product Quality6/25/097/22/09

Human drug finished product
(Warning Letter)

PDF

HTML

Laboratoire Atlas, Inc.Division of Manufacturing and Product Quality6/25/097/22/09

Clinical Investigator

Mark Gordon, M.D.Division of Scientific Investigations6/26/20097/7/09

Clinical Investigator

Dov Linzer, MDDivision of Scientific Investigations6/12/20096/12/2009

Clinical Investigator

Noli R Zosa, M.D.Division of Scientific Investigations6/16/20097/7/09

Velcade (bortezomib) for injection

Millennium Pharmaceuticals, Inc.Division of Drug Marketing, Advertising, and Communications6/18/20096/23/09

 

May 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Alinia (nitazoxanide) Tablets and (nitazoxanide) for Oral Suspension

Romark Laboratories, L.C.Division of Drug Marketing, Advertising, and Communications5/26/20096/22/09

PerioChip (chlorhexidine gluconate) (Warning Letter)

Dexcel Pharma Technologies Ltd.Division of Drug Marketing, Advertising, and Communications5/14/20095/19/2009

Spectracef (cefditoren pivoxil) Tablets (Warning Letter)

Cornerstone Therapeutics, Inc.Division of Drug Marketing, Advertising, and Communications5/4/20095/19/2009
ULTRAM ER (tramadol HCl) (Warning Letter)Johnson & JohnsonDivision of Drug Marketing, Advertising, and Communications5/12/20095/19/2009
Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu VirusAmrita Aromatherapy, IncOffice of Compliance5/28/20096/22/2009
Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu VirusNozin LLCOffice of Compliance5/22/20096/22/2009

 

April 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Clinical Investigator

Francisco Hernandez, MDDivision of Scientific Investigations4/20/20094/20/2009
Taxotere (docetaxel)sanofi-aventisDivision of Drug Marketing, Advertising, and Communications4/16/20095/13/2009
Institutional Review Board (Warning Letter)Coast IRBDivision of Scientific Investigations4/14/20094/14/2009

Site Inspection 

(Warning Letter)

Qingdao Jiulong Biopharmaceuticals Co. Ltd.Division of Manufacturing and Product Quality4/14/20094/16/2009

Clinical Investigator

Bruce Branitz, MDDivision of Scientific Investigations4/9/20094/9/2009

BLA 125104 Tysabri (natalizumab) injection for intravenous use

 

Biogen IdecDivision of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 20-839 Plavix (clopidogrel bisulfate) Tablets

Sanofi Aventis, U.S.Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-400 LEVITRA (vardenafil HCl) Tablets; NDA 21-676, 21-873, 22-045 YAZ (drospirenone and ethinyl estradiol) Tablets; NDA 21-225 Mirena (levonorgestrel-releasing intrauterine system)

Bayer Healthcare Pharmaceuticals, Inc.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-071 Avandia (rosiglitazone maleate) Tablets; NDA 21-410 Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets; NDA 21-700 Avandaryl (rosiglitazone maleate and glimepiride) Tablets; NDA 21-319 Avodart (dutasteride) Soft Gelatin Tablets; NDA 22-012 Coreg CR (carvedilol phosphate) Extended-release Capsules; NDA 22-059 Tykerb (lapatinib) Tablets

GlaxoSmithKlineDivision of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-742 BYSTOLIC (nebivolol) Tablets; NDA 21-431 CAMPRAL (acamprosate calcium) Delayed-Release Tablets; NDA 21-323, 21-365, 21-440 Lexapro (escitalopram) Tablets/ Oral Solution; NDA 21-487, 21-627 Namenda (memantine) Tablets/Oral Solution

Forest Laboratories, Inc.Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-947 FENTORA (fentanyl buccal tablet); NDA #22-249 TREANDA (bendamustine hydrochloride) for Injection, for intravenous infusion

Cephalon, Inc.Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-976 PREZISTA (darunavir) Tablet

Johnson & Johnson Pharmaceutical Services
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 20-753 AROMASIN (exemestane) tablets; NDA 21-540 CADUET (amlodipine besylate/atorvastatin calcium) Tablets; NDA 21-928 CHANTIX® (varenicline) Tablets; NDA 21-228 Detrol LA (tolterodine tartrate) extended release capsules; NDA 21-446, 21-723, 21-724 LYRICA (pregabalin) Capsules; NDA 20-998, 21-156 CELEBREX (celecoxib) capsules

Pfizer, Inc.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 20-726 Femara (letrozole tablets); NDA 21-283 Diovan (valsartan) Tablets; NDA 21-990 Exforge (amlodipine and valsartan) Tablets; NDA 21-882 EXJADE (deferasirox) Tablets for Oral Suspension; NDA 21-588 GLEEVEC (imatinib mesylate) Tablets for Oral Use

Novartis Pharmaceuticals Corp.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

BLA 125085 Avastin (Bevacizumab); BLA 125156 LUCENTIS (ranibizumab injection); BLA 103705, 103737 RITUXAN (rituximab); BLA 103976 Xolair (Omalizumab) For Subcutaneous Use; BLA 103792 HERCEPTIN (trastuzumab); BLA 103532 Pulmozyme (dornase alfa) Inhalation Solution

Genentech, Inc.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-395 Spiriva HandiHaler (tiotropium bromide inhalation powder); NDA 20-579 Flomax (tamsulosin hydrochloride) Capsules; NDA 20-667 Mirapex (pramipexole dihydrochloride) Tablets

Boehringer Ingelheim Pharmaceuticals, Inc.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-995 JANUVIA (sitagliptin) Tablets; NDA 20-788 PROPECIA (finasteride) Tablets; NDA 20-829, 20-830, 21-409 SINGULAIR (montelukast sodium) granule;
tablet, chewable; tablet, film coated; NDA 21-549 EMEND (aprepitant) Capsules

Merck & Co., Inc.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-455, 21-858 BONIVA (ibandronate sodium) Tablets; BLA 103964 PEGASYS (peginterferon alfa-2a) for Injection; NDA 20-896 XELODA (capecitabine) Tablets

Hoffman-LaRoche, Inc.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009

NDA 21-427, 21-733, 22-148 Cymbalta (duloxetine hydrochloride) Delayed-
Release Capsules for Oral Use; NDA 20-815, 22-042 EVISTA (raloxifene hydrochloride) Tablets for Oral Use; NDA 20-509 Gemzar (gemcitabine HCl) for Injection

 

 

Eli Lilly and Co.
 
Division of Drug Marketing, Advertising, and Communications4/2/20094/3/2009
March 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Clinical Investigator

(Warning Letter)

Ronald Bukowski, M.D.Division of Scientific Investigations3/30/20094/21/2009

Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml

Glenmark Generics, Inc.Office of Compliance3/30/20093/31/2009

Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Hydromorphone HCI Tablets, 2mg and 4mg

Lannett Company, Inc.Office of Compliance3/30/20093/31/2009

Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Concentrate, 20 mg/ml

Lehigh Valley Technologies, Inc.Office of Compliance3/30/20093/31/2009

Morphine Sulfate Concentrate Oral Solution 20mg/ml

Mallinckrodt Inc. Pharmaceuticals GroupOffice of Compliance3/30/20093/31/2009

Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg

Xanodyne Pharmaceuticals, Inc.Office of Compliance3/30/20093/31/2009

Morphine Sulfate Immediate Release Tablets, 30 mg; Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg

Physicians Total Care, Inc.Office of Compliance3/30/20093/31/2009

Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg

Roxane Laboratories, Inc.Office of Compliance3/30/20093/31/2009

Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg

Boehringer Ingelheim Roxane, Inc.Office of Compliance3/30/20093/31/2009

Morphine Sulfate Solution Immediate Release 20mg/ml

Cody Laboratories, Inc.Office of Compliance3/30/20093/31/2009

Clinical Investigator

Daniel M. Paulson, MDDivision of Scientific Investigations3/11/20093/11/2009

Treximet (sumatriptan and naproxen sodium) Tablets

GlaxoSmithKlineDivision of Drug Marketing, Advertising, and Communications3/9/20094/7/2009

Clinical Investigator (Warning Letter)

 

 

Charles J. Cote, M.D.Division of Scientific Investigations3/2/20093/3/2009

Clinical Investigator (Warning Letter)

 

 

Virendra Desai, M.D.Division of Scientific Investigations3/2/20093/5/2009

Clinical Investigator (Warning Letter)

 

 

Manuel J. Quinones, M.D.Division of Scientific Investigations3/3/20093/5/2009
February 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Avodart (dutasteride) Soft Gelatin Capsules

 

 

GlaxoSmithKlineDivision of Drug Marketing, Advertising, and Communications
 
2/18/20092/26/2009

Institutional Review Board

SUNY Downstate Medical Center, Health Science CenterDivision of Scientific Investigations2/11/20095/5/2010

Inspection of Pharmaceutical Manufacturing Facility (Warning Letter)

 

 

Barrie Levitt, M. D.Division of Manufacturing & Product Quality
 
2/5/20092/5/2009
Clinical InvestigatorChristopher Chappel, MDDivision of Scientific Investigations2/2/20092/2/2009
Letairis (ambrisentan)Gilead Sciences, Inc.Division of Drug Marketing, Advertising, and Communications2/27/20093/5/2009

January 2009
Product/IssueCompany/IndividualDivisionReleasedPosted

Clinical Investigator (Warning Letter)

 

 

 

Nicola Spirtos, M.DDivision of Scientific Investigations
 
1/3/20091/22/2009
Sponsor-InvestigatorGeorge J. Brewer, MDDivision of Scientific Investigations1/14/20091/14/2009
Clinical InvestigatorDr. Lynette StewartDivision of Scientific Investigations1/21/20091/21/2009

Depakote (divalproex sodium)

 

Abbott Laboratories    Division of Drug Marketing, Advertising, and Communications   
 
1/22/2009    1/29/2009     

Sanctura (trospium chloride)

 

 

Indevus Pharmaceuticals, Inc.Division of Drug Marketing, Advertising, and Communications1/27/20091/29/2009

 

 

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.

The letters are arranged in chronological order by month.  Click on the product name to view the letters in Adobe Acrobat (PDF) format.