FDA Warning Letters indexed by Company Names

Link:  Pharm/Biotech Resources

 

21st Century Sports Nutritionals, Inc.

1. 21st Century Sports Nutritionals, Inc. (Phenylkinetics, Libido Magic)

2bbrands.com/drugstore

1. 2bbrands.com/drugstore (Accutane)

3M Pharmaceuticals

1. 3M Pharmaceuticals (Maxair^TMAutohaler^TM (pirbuterol acetate inhalation aerosol))
    
2. 3M Pharmaceuticals (Tambocor (flecainide acetate) Tablets)

Abbott Laboratories

1. Abbott Laboratories (Survanta®(beractant) intratracheal suspension)
    
2. Abbott Laboratories (Kaletra (lopinavir/ritonavir) Capsules and Oral Suspension)
    
3. Abbott Laboratories (Norvir (ritonavir capsules) Soft Gelatin)
    
4. Abbott Laboratories (Mivacron (mivacurium chloride) Injection)

ACS Dobfar

1. ACS Dobfar (Site Inspection)

Actelion Pharmaceuticals US, Inc.

1. Actelion Pharmaceuticals US, Inc. (Tracleer (bosentan) Tablets)
    
2. Actelion Pharmaceuticals US, Inc. (Tracleer (bosentan) Tablets)

Alcon Research/Alcon Laboratories

1. Alcon Laboratories, Inc. (Ciprodex (ciprofloxacin) sterile otic suspension)
    
2. Alcon Research, Inc. (NevanacTM (nepafenac ophthalmic suspension) 0.1%)
    
3. Alcon Research, Ltd. (Travatan® (travoprost ophthalmic solution) 0.004%)
    
4. Alcon Laboratories, Inc. (CIPRO HC Otic)
    
5. Alcon Research Ltd. (Cipro HC Otic Suspension and Ciloxan)
    
6. Alcon Research Ltd.(Patanol (olopatadine hydrochloride ophthalmic solution) 0.1%)
    
   
7. Alcon Laboratories (Ciloxan (ciprofloxacin HCL) Ophthalmic Solution)

Aliachem A.S.

1. Aliachem A.S. (API Site Inspection)

Allergan, Inc.

1. Allergan, Inc. (ACULAR LS® (ketorolac tromethamine ophthalmic solution) 0.4%)
    
2. Allergan, Inc. (Lumigan (bimatoprost ophthalmic solution) 0.03%)
    
3. Allergan, Inc. (Lumigan (bimatoprost ophthalmic solution) 0.03%)
    
   
4. Allergan, Inc. (Alphagan (brimonidine tartrate ophthalmic solution) 0.2%)
    
   
5. Allergan Inc. (Azelex (Azelaic Acid) 20% Cream)
    
   
6. Allergan, Inc. (Alocril (nedocromil sodium ophthalmic solution), 2%)

Alza Corporation

1. Alza Corporation (Viadur® (leuprolide acetate implant))
    
2. Alza Corporation (Ditropan XL® (oxybutynin chloride) Extended-Release Tablets)
    
   
3. Alza Corporation (Doxil® (doxorubicin HCL liposome injection))
    
   
4. Alza Corporation (Ditropan® XL (oxybutynin chloride) Extended Release Tablets)
    
   
5. Alza Corporation (Ditropan XL (oxybutynin chloride) Extended Release Tablets)
    
   
6. Alza Corporation (Doxil® (doxorubicin HCl liposome injection))

American Regent Laboratories, Inc.

1. American Regent Laboratories, Inc. (Venofer (Iron Sucrose Injection))

Ames Periodontal Specialists

1. Ames Periodontal Specialists (BMIS Inspection)

Amgen, Inc.

1. Amgen, Inc. (Enbrels (etanercept))

The Asthma and Allergy Institute

1. The Asthma and Allergy Institute (Clinical Study Inspection)

Ashland Drug

1. Ashland Drug (Nicotine Lollipops)

Astellas Pharma US, Inc.

1. Astellas Pharma US, Inc. (Prograf (tacrolimus capsules and injection))

AstraZeneca

1. AstraZeneca (Seroquel® (quetiapine fumarate) Tablets)
    
2. AstraZeneca (Crestor®(rosuvastatin calcium) Tablets)
    
3. AstraZeneca (Crestor® (rosuvastatin calcium) Tablets)
    
4. AstraZeneca (Merrem I.V. (meropenem for injection))
    
5. AstraZeneca (Nolvadex® (tamoxifen citrate) Tablets)
    
   
6. AstraZeneca (Zomig© (zolmitriptan) Tablets, 2.5 mg and 5 mg)
    
   
7. AstraZeneca (IND No: ZD1839, ZD0473, ZD1694, ZD9238, & Arimidex (ansastrozole) tablets)
    
   
8. AstraZeneca (Diprivan (propofol) Injectable Emulsion)
    
   
9. AstraZeneca (Nolvadex® (tamoxifen citrate))
    
   
10. AstraZeneca (Prilosec (omeprazole) Delayed-Release Capsules)
     
    
11. AstraZeneca L.P. (Accolate (zafirkulast) Tablets)
     
    
12. Astra Zeneca (Prilosec (omeprazole) Delayed-Release Capsules)
     
    
13. AstraZeneca (Plendil (felodipine) extended-release tablets)

Aventis Pharmaceuticals

1. Aventis Pharmaceuticals (Allegra® (fexofenadine HCl) Tablets)
    
2. Aventis Pharmaceuticals (Taxotere (docetaxel) for Injection Concentrate)
    
3. Aventis Pharmaceuticals (Taxotere (docetaxel) for Injection)
    
   
4. Aventis Pharmaceuticals (Lovenox (enoxaparin sodium) Injection)
    
   
5. Aventis Pharmaceuticals (Nilandron® (nilutamide) Tablets)
    
   
6. Aventis Pharmaceuticals (Amaryl® (glimepiride) Tablets)
    
   
7. Aventis Pharmaceuticals (Allegra (fexofenadine hydrochloride) Capsules 60 mg) 

Avlon Industries

1. Avlon Industries (BMIS Inspection)

Axium Healthcare Pharmacy

1. Axium Healthcare Pharmacy (Domperidone)

Barr Research, Inc.

1. Barr Research, Inc. (Seasonale® (levonorgestrel/ethinyl estradiol) Tablets)

Bausch & Lomb Pharmaceuticals Inc.

1. Bausch & Lomb (Alrex (loteprednol etabonate ophthalmic suspension, 0.2%)) 

Baxter Pharmaceutical Products, Inc.

1. Baxter Pharmaceutical Products, Inc. (Brevibloc (esmolol hydrochloride) Injection)

Bayer Corporation

1. Bayer Pharmaceuticals Corporation (Levitra° (vardenafil HCl) Tablets)
    
2. Bayer Corporation (Avelox (moxifloxacin HCL))
    
   
3. Bayer Corporation (Vardenafil)
    
   
4. Bayer Corporation (Avelox (moxifloxacin hydrochloride) Tablets

Berlex Laboratories

1. Berlex Laboratoris (Yasmin (drospirenone/ethinyl estradiol) Tablets)
    
2. Berlex Laboratories (Quadramet (Samarium Sm-153 lexidronam) Injection)
    
   
3. Berlex Laboratories (Magnevist (gadopentetate dimeglumine) Injection)
    
   
4. Berlex Laboratories (Fludara® (fludarabine phosphate) for injection)

Better-Bodies

1. Better-Bodies (Adipokinetix)

Bigmar-Bioren SA

1. Bigmar-Bioren SA (Site Inspection)

Bio-Health

1. Bio-Health (Z-LABS Progesterone Cream)

Biogen Idec, Inc.

1. Biogen Idec, Inc. (Zevalin® (ibritumomab tiuxetan))

BioMarin Pharmaceutical, Inc.

1. BioMarin Pharmaceutical, Inc. (Orapred® (prednisolone sodium phosphate oral solution))

Bioniche Pharma Group Limited

1. Bioniche Pharma Group Limited (Sotradecol (sodium tetradecyl sulfate injection))

Biovail Pharmaceuticals

1. Biovail Pharmaceuticals (Cedax® (ceftibuten))

Bird's Hill Pharmacy

1. Bird's Hill Pharmacy (Nicotine Lollipops)

B.F. Ascher & Company, Inc.

1. B.F. Ascher & Company, Inc. (Melagesic PM Caplets)

Block Drug Company, Inc.

1. Block Drug Company, Inc. (Atridox (doxycycline hyclate, 10%))

Boehringer Ingelheim Pharmaceuticals, Inc.

1. Boehringer Ingelheim Pharmaceuticals, Inc. (Spiriva® Handihaler® (tiotropium bromide inhalation powder))
    
2. Boehringer Ingelheim Pharmaceuticals, Inc. (Aggrenox® (aspirin/extended-release dipyridamole) Capsules)
    
3. Boehringer Ingelheim Pharmaceuticals, Inc. (Viramune (nevirapine) Tablets and Viramune (nevirapine) Oral Suspension)
    
4. Boehringer Ingelheim Pharmaceuticals, Inc. (Atrovent (ipratropium bromide) Inhalation Aerosol and Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol)
    
5. Boehringer Ingelheim Pharmaceuticals, Inc. (Viramune (nevirapine) Tablets and Oral Suspension)

Bracco Diagnostics, Inc.

1. Bracco Diagnostics, Inc.(MultiHance (gadobenate dimeglumine, Gd-BOPTA))

Bradley Pharmaceuticals

1. Bradley Pharmaceuticals (Pamine (methscopolamine bromide))

Braintree Laboratories Inc.

1. Braintree Laboratories Inc. (Phoslo (calcium acetate) tablets)

Bristol-Myers Squibb

1. Bristol-Myers Squibb (Pravachol (pravastatin sodium) Tablets)
    
2. Bristol-Myers Squibb (UFT (uracil and tegafur) capsules)
    
   
3. Bristol-Myers Squibb (Ifex® (ifosfamide) Injection)
    
   
4. Bristol-Myers Squibb (Vaniqa (eflornithine hydrochloride) Cream, 13.9%)
    
   
5. Bristol-Myers Squibb (Tequin (gatifloxacin) Tablets/Injection)
    
   
6. Bristol-Myers Squibb ( Hydrea and Droxia capsules)

CanaRx Services, Inc.

1. CanaRx Services, Inc. (Prescription Drug Shipments)

Cape Drugs

1. Cape Drugs (Domperidone)

Carter Wallace

1. Carter Wallace (Astelin (azelastine HC1) Nasal Spray)

Celgene Corporation

1. Celgene Corporation (Thalomid (thalidomide) Capsules)

Central Pennsylvania Clinical Research

1. Central Pennsylvania Clinical Research (Celebrex (celecoxib) capsules)

Centocor, Inc.

1. Centocor, Inc. (Remicade® (infliximab))

Cephalon, Inc.

1. Cephalon, Inc. (Provigil® (modafinil) Tablets [C-IV])
    
2. Cephalon Inc. (Provigil (modafinil) Tablets)

Changzhou SPL Company, Ltd

1. Changzhou SPL Company, Ltd (Site Inspection)

CIBA Vision

1. CIBA Vision (Rescula (unoprostone isopropyl ophthalmic solution), 0.15%)

Clinical Site (Alkis Togias, M.D.)

1. Clinical Site (Alkis Togias, M.D.)

Clonmel Healthcare Ltd.

1. Clonmel Healthcare Ltd. (Inspection Report)

Coast Institutional Review Board

1. Coast Institutional Review Board (Site Inspection)

Colleganex Pharmaceuticals, Inc.

1. Colleganex Pharmaceuticals (Periostat (doxycycline hyclate), 20 mg Capsules)

The Compounding Pharmacy

1. The Compounding Pharmacy (Nicotine Lollipops and Nicotine Lip Balm)

Comprehensive Clinical Research

1. Comprehensive Clinical Research (Clinical Study Inspection)

Connetics Corporation

1. Connetics Corp. (Luxig^TM (betamethasone valerate) Foam, 0.12%)
    
   
2. Connetics Corp. (Luxig^TM (betamethasone valerate) Foam, 0.12%)

Corixa Corporation

1. Corixa Corporation (BEXXAR® (Tositumomab and Iodine I 131 Tositumomab))

Coulston Foundation

1. Coulston Foundation (Site Inspection)

Critical Therapeutics, Inc.

1. Critical Therapeutics, Inc. (Zyflo® Filmtab® (zileuton tablets))

Cubist Pharmaceuticals, Inc.

1. Cubist Pharmaceuticals (Cubicin^TM (daptomycin for injection))
    
2. Cubist Pharmaceuticals (Daptomycin)

Cytogen Corporation

1. Cytogen Corporation (Quadramet (Samarium SM 153 Lexidronam) Injection)

Daiichi Sankyo, Inc.

1. Daiichi Sankyo, Inc. (Evoxac Capsules (cevimeline hydrochloride))

DAVA Pharmaceuticals, Inc.

1. DAVA Pharmaceuticals, Inc. (VoSpire ER® (albuterol sulfate) Extended-Release Tablets)

Delta Synthetic Co., Ltd

1. Delta Synthetic Co., Ltd (API Site Inspection)

Dey Laboratories

1. Dey Laboratories (Ipratropium Bromide inhalation Solution 0.02%)

Diabetes Tea

1. Diabetes Tea (Overdrive)

Discount Prescriptions from Canada, Inc.

1. Discount Prescriptions from Canada, Inc. (Prescription Drugs Importation)

Discovery Alliance, Inc.

1. Discovery Alliance, Inc. (Clinical Study)

Discovery Experimental & Development Inc

1. Discovery Experimental & Development Inc (Liquid Deprenyl Citrate)

Doak Dermatologics

1. Doak Dermatologics (Solaraze (diclofenac sodium) Gel, 3 %)

DuPont Pharmaceuticals Company

1. DuPont Pharmaceuticals Company (Sustiva (efavirenz) capsules)
    
   
2. DuPont Pharmaceuticals Company (Innohep (tinzaparin sodium injection))

Duramed Pharmaceuticals, Inc.

1. Duramed Pharmaceuticals, Inc. (Cenestin ® (synthetic conjugated estrogens, A) Tablets)

DUSA Pharmaceuticals, Inc.

1. DUSA Pharmaceuticals, Inc. (Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20%)

Dutch Ophthalmic USA

1. Dutch Ophthalmic USA (VisionBlue® (trypan blue ophthalmic solution))

Elan Pharmaceuticals

1. Elan Pharmaceuticals (Zanaflex (tizanidine HCl) Tablets)
    
2. Elan Pharmaceuticals (Zanaflex (tizanidine HCl) Tablets)
   
   
3. Elan Pharmaceuticals (Corlopam (fenoldopam mesylate) Injection)

Eli Lilly and Company

1. Eli Lilly and Company (CYMBALTA© (duloxetine hydrochloride) Delayed-release Capsules)
    
2. Eli Lilly and Company (Alimta® pemetrexed for injection)
    
3. Eli Lilly and Company (Strattera (atomoxetine HCl))
    
4. Eli Lilly and Company (Sarafem (fluoxetine HCI) Tablets)
    
   
5. Eli Lilly and Company (Evista (raloxifene HCl) Tablets)
    
   
6. Eli Lilly and Company (IND Promotion)
    
   
7. Eli Lilly and Company (Tapazole (methimazole))

Endo Pharmaceuticals Inc.

1. Endo Pharmaceuticals (Lidoderm® (Lidocaine Patch 5%))
    
2. Endo Pharmaceuticals (Zydone (hydrocodone bitartrate and acetaminophen tablets)

Enzon Pharmaceuticals, Inc.

1. Enzon Pharmaceuticals, Inc. (Abelcet® (Amphotericin B Lipid Complex Injection))

Evangeline G. Gonzalez, M.D.

1. BMIS Inspection (Warning Letter)

Expedite-Rx

1. Expedite-Rx (Prescription Drug Importation)

FIDIA s.p.a.

1. FIDIA s.p.a. (Site Inspection)

Forest Laboratories, Inc

1. Forest Laboratories, Inc. (Celexa (citalopram HBr))
    
2. Forest Laboratories, Inc. (Levothroid (levothyroxine sodium tablets, USP))

Fujisawa Healthcare, Inc.

1. Fujisawa Healthcare, Inc. (Prograf® (tacrolimus))
    
2. Fujisawa Healthcare, Inc. (Protopic (tacrolimus) Ointment 0.03%, 0.1%)
    
   
3. Fujisawa Healthcare, Inc. (Protopic (tacrolimus 0.03% and 0.1%) Ointment)

G.D. Searle & Co.

1. G.D. Searle & Co. (Celebrex (celecoxib) capsules)
    
   
2. G.D. Searle & Co. (Celebrex (celecoxib) capsules and Anibien (zolpidem tartrate) tablets) 

Galderma Laboratories, L.P.

1. Galderma Laboratories (Differin (adapalene gel) Gel, 0.1%)

GelTex Pharmaceuticals

1. GelTex Pharmaceuticals (Renagel Capsules/Tablets)

Gemeindezentrum

1. Gemeindezentrum (Site Inspection)

Gene Logic, Inc.

1. Gene Logic, Inc. (BMIS Inspection)

Genetech

1. Genentech (Nutropin)
    
2. Genetech (Nutropin Depot [somatropin (rDNA origin) for injectable suspension])

Genpharm, Inc.

1. King & Spaulding (For Genpharm) (Amnesteem (isotretinoin) Capsules)

Genzyme Corporation

1. Genzyme Corporation (Cerezyme (imiglucerase for injection))

Gilead Sciences

1. Gilead Sciences (Viread® (tenofovir disoproxil fumarate) Tablets)
    
2. Gilead Sciences (Viread® (tenofovir disoproxil fumarate) Tablets)

GlaxoSmithKline/Glaxo Wellcome

1. GlaxoSmithKline, Inc. (TYKERB (lapatinib) Tablets)
    
2. GlaxoSmithKline, Inc. (Flonase® (fluticasone propionate) Nasal Spray, 50 mcg
    
3. GlaxoSmithKline, Inc. (Zovirax® (acyclovir) Ointment 5%)
    
4. GlaxoSmithKline, Inc. (Coreg (carvedilol) Tablets)
    
5. GlaxoSmithKline, Inc. (Paxil® CR (paroxetine HCl) Controlled Release Tablets)
    
6. GlaxoSmithKline, Inc. (Flonase (fluticasone propionate) Nasal Spray, 50 mcg)
    
7. GlaxoSmithKline, Inc. (Imitrex (sumatriptan succinate) Tablets)
   
   
8. GlaxoSmithKline Inc. (Avandia® (rosiglitazone maleate) Tablets)
    
   
9. GlaxoSmithKline Inc. (Avandia® (rosiglitazone maleate) Tablets)
    
   
10. GlaxoSmithKline Inc. (Navelbine® (vinorelbine tartrate) Injection)
     
    
11. Glaxo Wellcome, S.p.A. (Site Inspection)
     
    
12. Glaxo Wellcome (Flovent (fluticasone propionate) Inhalation Aerosol)
      
    
13. Glaxo Wellcome (LOTRONEX (alosetron hydrochloride) Tablets)
     
    
14. Glaxo Wellcome (Relenza (zanamivir for inhalation))
     
    
15. Glaxo Wellcome (Flonase (fluticasone propionate) Nasal Spray (Newspaper))
     
    
16. Glaxo Wellcome (Flonase (fluticasone propionate) Nasal Spray (TV))

Granules India Limited

1. Granules India Limited (Site Inspection)

Guilford Pharmaceuticals, Inc.

1. Guilford Pharmaceuticals, Inc. (Gliadel Wafer (polifeprosan 20 with carmustine implant))

Hemispherx Biopharma, Inc.

1. Hemispherx Biopharma, Inc. (Ampligen)

Herbtech

1. Herbtech (Ephedra or Ma Huang)

Heyltex Corporation

1. Heyltex Corporation (IND Inspection)

Hoffmann-La Roche

1. Hoffman-La Roche Inc. (FuzeonTM (enfuvirtide) for Injection)
    
2. Hoffmann-La Roche Inc. (Xeloda® (capecitabine) Tablets)
    
3. Hoffmann-LaRoche, Inc. (Accutane (isotretinoin) Capsules)
    
4. Hoffman-La Roche, Inc. (Tamiflu (oseltamivir phosphate) Capsules)
   
   
5. Hoffmann-La Roche, Inc. (Xeloda® (capecitabine) Tablets)
   
   
6. Hoffman-La Roche, Inc. (TAMIFLU (oseltamivir phosphate))
    
   
7. Hoffman La Roche Inc. (Xenical (orlistat) Capsules)
    
   
8. Hoffmann-La Roche (Xenical (orlistat tetrahydrolipstatin))

Herron, Jerry M. M.D.

1. Jerry M. Herron, M.D. (BMIS Inspection)

Human Investigation Committee of Houston, Texas

1. Human Investigation Committee of Houston, Texas (IRB Inspection)

ICN Pharmaceuticals, Inc.

1. ICN Pharmaceuticals (Efudex® (fluorouracil) topical solutions and cream)

Institute for Advanced Clinical Research

1. Institute for Advanced Clinical Research (Clinical Study)

InterMune, Inc.

1. InterMune, Inc. (INFERGEN® (Interferon alfacon-1))

ISTA Pharmaceuticals, Inc.

1. ISTA Pharmaceuticals, Inc. (Vitrase (hyaluronidase injection))

ITT Research Institute

1. ITT Research Institute (Inspection)

Janssen Pharmaceuticals Inc./Research Foundation

1. Janssen Pharmaceutica, Inc. (Duragesic® (fentanyl transdermal system) CH)
    
2. Janssen Pharmaceutica, Inc. (Risperdal® (risperidone))
    
3. Janssen Research Foundation (Reminyl (galantamine HBr))
    
4. Janssen Research Foundation (Sporanox (Itraconazole) Capsules)
    
   
5. Janssen Pharmaceuticals Inc. (Sporanox (itraconazole) Capsules)

Jerome Stevens Pharmaceuticals, Inc.

1. Jerome Stevens Pharmaceuticals Inc. (THYROX (Levothyroxine Sodium Tablets, USP))

Jiangsu Hengrui Medicine Co., LTD.

1. Jiangsu Hengrui Medicine Co., LTD. (Site Inspection)
    
   
2. Jiangsu Hengrui Medicine Co., LTD. (Site Inspection)

JIIM, L.L.C.

1. JIIM, L.L.C. (Doctor's Lotion)

Johnson & Johnson Consumer Companies, Inc.

1. Johnson & Johnson Consumer Companies, Inc. (Retin-A Micro (tretinoin gel) microsphere, 0.1%)
    
2. Johnson & Johnson Consumer Companies, Inc. (Renova (tretinoin emollient cream) 0.05%)

Jones Pharma Inc.

1. Jones Pharma Incorporated (Levoxyl, levothyroxine sodium tablets, USP)

Kalchem International, Inc.

1. Kalchem International, Inc. (Pharmacy Compounding of Domperidone)

King Pharmaceuticals, Inc.

1. King Pharmaceuticals, Inc. (Avinza® (morphine sulfate extended-release capsules) CII)
    
2. King Pharmaceuticals (Altace (ramipril) Capsules)

Knoll Pharmaceutical

1. Knoll Pharmaceutical (Synthroid (levothyroxine sodium) Tablets)

Kos Pharmaceuticals

1. Kos Pharmaceuticals (Niaspan (niacin extended-release) Tablets)

Kunshan Chemical & Pharmaceutical Company

1. Kunshan Chemical & Pharmaceutical Company (Site Inspection)

KV Pharmaceutical Company

1. KV Pharmaceutical Company (Clindesse^TM (clindamycin phosphate) Vaginal Cream, 2%)

Lifecycle Ventures

1. Lifecycle Ventures (Ceftin Tablets(cefuroxime axetil tablets))

Ligand Pharmaceuticals, Inc.

1. Ligand Pharmaceuticals, Inc. (ONTAK (denileukin diftitox) and Targretin (bexarotene) capsules)
    
2. Ligand Pharmaceuticals Inc. (Targretin® (bexarotene) capsules)

Lilly ICOS LLC

1. Lilly ICOS LLC (IC351)

Linden Research Consultant

1. Linden Research Consultant (BMIS Inspection)

Litron Laboratories, Ltd.

1. Litron Laboratories, Ltd. (Inspection)

Long March Pharmaceuticals

1. Long March Pharmaceuticals (Site Inspection)

Mallinckrodt, Inc.

1. Mallinckrodt, Inc. (Tramadol Hydrochloride Tablets, 50 mg)

Maxim Pharmaceuticals, Inc.

1. Maxim Pharmaceuticals, Inc.  (CepleneTM (histamine dihydrochloride) for Injection)
    
   
2. Maxim Pharmaceuticals, Inc. (Histamine Dihydrochloride Injection)

Mayne Pharma Pty., Ltd.

1. Mayne Pharma (USA), Inc. (M.V.I.-12 (Multi-Vitamin Infusion without vitamin K))
    
2. Mayne Pharma Pty., Ltd. (Site Inspection)

MD Anderson Cancer Center

1. MD Anderson Cancer Center (Inspection)

MDS Pharma Services/MDS Inc.

1. MDS Inc. (BIMO Inspection)
    
2. MDS Pharma Services (BMIS Inspection)
    
3. MDS Pharma Services (Facility Inspection)

Medicis Pharmaceutical Corp.

1. Medicis Pharmaceutical Corp. (Loprox Shampoo (ciclopirox))
    
2. Medicis Pharmaceutical Corp. (Loprox (ciclopirox) 0.77% Cream and Lotion)

MedImmune

1. MedImmune Oncology Inc. (Ethyol® (amifostine) for Injection)

Merck & Co. Inc.

1. Merck & Co. Inc. (Vioxx (rofecoxib) tablets)
    
   
2. Merck & Co. Inc. (Cancidas (caspofungin acetate))
    
   
3. Merck & Co. Inc. (Fosamax (alendronate sodium tablets))
    
   
4. Merck & Co. Inc. (Crixivan (indinavir sulfate) tablets)
    
   
5. Merck & Co. Inc. (Fosamax (alendronate sodium) and Vioxx (rofecoxib)

MGI Pharma, Inc.

1. MGI Pharma, Inc. (Gliadel® Wafer (polifeprosan 20 with carmustine implant))

Moscow City Hospital

1. Moscow City Hospital, Professor Olga D. Ostroumova (Clinical Inspection)

Murray, Robert Michael MD

1. Robert Michael Murray, MD (BMIS Inspection)

Muscle Lane, Inc.

1. Muscle Lane, Inc. (Adrenalin)

Nabi

1. Nabi (Aloprim (allopurinol sodium) for Injection)

Nephrx

1. Nephrx (Calcitriol Injection 1 mcg/mL)

Niagara Pharmaceuticals Inc.

1. Niagara Pharmaceuticals Inc. (Site Inspection)

North American Science Associates, Inc.

1. North American Science Associates, Inc. (BMIS Inspection)

Northeast General Pharmaceutical Factory

1. Northeast General Pharmaceutical Factory (Site Inspection)

Novartis Ophthalmics

1. Novartis Ophthalmics (Zaditor (ketotifen fumarate ophthalmic solution), 0.025%)

Novartis Pharmaceuticals Corporation

1. Novartis Pharmaceuticals (Trileptale (oxcarbazepine) Tablets and Oral Suspension)
    
2. Novartis Pharmaceuticals (Exelon® (rivastigmine tartrate) Capsules and Oral Solution)
    
3. Novartis Pharmaceuticals (Diovan® (valsartan) Tablets)
    
4. Novartis Pharmaceuticals (Lamisil® (terbinafine hydrochloride) 250 mg Tablets)
    
5. Novartis Pharmaceuticals (Transderm Scop (scopolamine) Transdermal Therapeutic System)
    
6. Novartis Pharmaceuticals (Comtan® (entacapone) Tablets)
    
7. Novartis Pharmaceuticals (Transderm Scop (scopolamine) Transdermal Therapeutic System)
    
8. Novartis Pharmaceuticals (Miacalcin Nasal Spray and Exelon Capsules)
    
9. Novartis Pharmaceuticals Corporation (Femara (letrozole) Tablets
    
10. Novartis Pharmaceuticals Corporation (Neoral Soft Gelatin Capsules, Neoral Oral Solution)
     
11. Novartis Pharmaceuticals Corporation (Diovan (valsartan) Capsules)
     
12. Novartis Pharmaceuticals Corporation (Lescol (fluvastatin sodium) Capsules)

Novo Nordisk Pharmaceuticals

1. Novo Nordisk Pharmaceuticals (Prandin (repaglinide) Tablets)

Omicron Quimica, S.A.

1. Omicron Quimica, S.A. (Site Inspection)

Omni Nutraceuticals

1. Omni Nutraceuticals (Inholtra Joint Pain Caplets and Inholtra Joint Pain Plus Caplets)

Optima Worldwide, Ltd

1. Optima Worldwide, Ltd (GEDA PLUS^TM and SURETE^TM)

Organon, Inc.

1. Organon, Inc. (Follistim® (follitropin beta for injection) )

Ortho-McNeil Pharmaceutical, Inc.

1. Ortho-McNeil Pharmaceutical, Inc. (Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkles)

Ozelle Pharmaceuticals

1. Ozelle Pharmaceuticals (Anvirzel ^TM)

Palatin Technologies, Inc.

1. Palatin Technologies, Inc. (NeutroSpecTM [Kit for the Preparation of Technetium (99m Tc) fanolesomab])

Pfizer Inc.

1. Pfizer, Inc. (Viagra® (sildenafil citrate) Tablets)
    
2. Pfizer, Inc. (Zoloft® (sertraline HCl) Tablets)
    
3. Pfizer, Inc. (Zyrtec® (cetirizine HCl) Tablets, Syrup, and Chewable Tablets)
    
4. Pfizer, Inc. (Celebrex & Bextra)
    
5. Pfizer, Inc. (Viagra® (sildenafil citrate) Tablets)
    
6. Pfizer, Inc. (Zyrtec-D 12 Hour® (cetirizine HC15 mg/pseudoephedrine HCl 120 mg) Extended Release Tablets)
    
7. Pfizer, Inc. (Camptosar® (irinotecan hydrochloride injection))
    
8. Pfizer Inc. (Covera-HS® (verapamil hydrochloride))
    
9. Pfizer Inc. (Geodon (ziprasidone HCI))
    
10. Pfizer Inc. (Lipitor (atorvastatin calcium) Tablets)
     
11. Pfizer, Inc. (Neurontin® (gabapentin))
     
12. Pfizer, Inc. (Zyrtec (cetirizine HCl) Tablets)
    
    
13. Pfizer Pharmaceuticals (Lipitor (atorvastatin calcium) Tablets)
     
    
14. Pfizer Pharmaceuticals (Neurontin (gabapentin))
     
    
15. Pfizer Pharmaceuticals (Estrostep (norethindrone acetate and ethinyl estradiol) Tablets)
     
    
16. Pfizer Pharmaceuticals (Zithromax (azithromycin for oral suspension))
     
    
17. Pfizer Pharmaceuticals (Viagra (sildenafil citrate) tablets)

PharmaKinetics Laboratories Inc.

1. PharmaKinetics Laboratories Inc. (Site Inspection)

PharmaMar, USA, Inc.

1. PharmaMar, USA, Inc. (Ecteinasicidin-743)

Pharmcia Corporation

1. Pharmacia Corporation (Xalatan (latanoprost ophthalmic solution))
   
   
2. Pharmacia Corporation (Genotropin (somatropin [rDNA] origin for injection))
    
   
3. Pharmacia Corporation (Celebrex (celecoxib) capsules)
    
   
4. Pharmacia Corporation (Site Inspection, Stockholm, Sweden)
    
   
5. Pharmacia Corporation (Site Inspection, Strangnas, Sweden)
    
   
6. Pharmacia & Upjohn (Detrol (tolterodine tartrate tablets))
    
   
7. Pharmacia & Upjohn, S.p.A. (Site Inspection)
    
   
8. Pharmcia & Upjohn (Camptosar Injection (irinotecan HCI injection))

Pliva Croatia Ltd.

1. Pliva Croatia Ltd. (Site Inspection)

Praecis Pharmaceuticals Incorporated

1. Praecis Pharmaceuticals (Plenaxis^TM (abarelix for injectable suspension))

Presutti Laboratories, Inc.

1. Presutti Laboratories, Inc. (Tindamax^TM (tinidazole tablets))

PrimaPharm, Inc.

1. PrimaPharm, Inc. (HydaseTM (hyaluronidase Injection, USP) 150 Units/mL)

Procter & Gamble Pharmaceuticals, Inc.

1. Procter & Gamble (Actonel (risedronate sodium tablets))

Purdue Pharma L.P.

1. Purdue Pharma L.P. (OxyContin© (oxycodone HCl controlled-release) Tablets)
    
2. Purdue Pharma L.P. (OxyContin (oxycodone hydrochloride Controlled-Release) tablets)

Radiant Research

1. Radiant Research (Clinical Study)

Ranbaxy Laboratories Limited

1. Ranbaxy Laboratories Limited (Site Inspection)

Raymond E. Tidman, M.D.

1. Raymond E. Tidman, M.D. (Clinical Investigation Inspection)

Reliant Pharmaceuticals, Inc.

1. Reliant Pharmaceuticals, Inc. (Rythmol© SR (propafenone HCl) extended release Capsules)

Replidyne, Inc.

1. Replidyne, Inc. (BMIS Inspection)

Research Consortium, Inc.

1. Research Consortium, Inc. (Bioreaserch Monitoring)

Roche Laboratories, Inc.

1. Roche Laboratories (Tasmar (tolcapone) Tablets)

Rochester General Hospital 

1. Rochester General Hospital (Clinical Study)

Sandoz, Inc.

1. Sandoz, Inc. (Ergotamine Tartrate)
    
2. Sandoz, Inc. (Bupropion hydrochloride extended-release tablets (SR))

Sankyo Pharma, Inc.

1. Sankyo Pharma, Inc. (Benicar (olmesartan))

Sanofi-Aventis

1. Sanofi-Aventis (BMIS Inspection)

Sanofi Pasteur, Inc.

1. Sanofi Pasteur, Inc. (Site Inspection)

Sanofi-Synthelabo, Inc.

1. Sanofi-Synthelabo Inc. (Plavix (clopidogrel bisulfate) 75 mg Tablets)
    
   
2. Sanofi-Synthelabo, Inc. (Plavix (clopidogrel bisulfate) Tablets)
    
   
3. Sanofi-Synthelabo, Inc. (Eloxatin (oxaliplatin))

Santen, Inc.

1. Santen Inc. (Quixin (levofloxacin ophthalmic solution), 0.5%)

Schering Corporation

1. Schering Corporation (Nasonex® (mometasone furoate monohydrate) Nasal Spray, 50 mcg)
    
2. Schering Corporation (Foradil Aerolizer® (formoterol fumarate inhalation powder) 12mcg)
    
3. Schering Corporation (Temodar® (temozolomide) Capsules)
    
   
4. Schering Corporation (Nasonex® (mometasone furoate monohydrate) Nasal Spray)
    
   
5. Schering Corporaton (Claritin (loratadine) Tablets)
    
   
6. Schering Corporaton (Claritin (loratadine) Tablets)
    
   
7. Schering Corporation (Claritin (loratadine) Tablets)

Scientifically Advanced Nutrition

1. Scientifically Advanced Nutrition (Hollywood Cuts)

Scios, Inc.

1. Scios, Inc. (Natrecor© (nesiritide) for Injection)

Sepracor, Inc.

1. Sepracor (Xopenex (levalbuterol HC1) Inhalation Solution)

Shanghai Medical Ltd.

1. Shanghai Medical Ltd. (Facility Inspection)

Shanghai Shen Xin Pharmaceutical Factory

1. Shanghai Shen Xing Pharmaceutical Factory  (Site Inspection)

Shire Laboratories, Inc.

1. Shire Development, Inc. (Fosrenol® (lanthanum carbonate))
    
2. Shire Pharmaceutical Development, Inc. (ProAmatine (midodrine hydrochloride) Tablets)
    
   
3. Shire Laboratories, Inc. (Fareston (toremifene citrate))

Sigma-Tau Pharmaceuticals Inc.

1. Sigma-Tau Pharmaceuticals Inc.  (Carnitor, levocarnitine)

Similasan AG

1. Similasan AG (Site Inspection)

Sitek Research Laboratories

1. Sitek Research Laboratories (BMIS Inspection)

SkyePharma

1. SkyePharma ( DepoCyto® (cytarabine liposome injection))

SmithKline Beecham Pharmaceuticals

1. SmithKline Beecham Pharmaceuticals (Argatroban Injection (100mg/mL))
    
2. SmithKline Beecham Pharmaceuticals (Avandia® (rosiglitazone nialeate) Tablets)
    
3. SmithKline Beecham Pharmaceuticals (Famvir (famciclovir))
    
4. SmithKline Beecham Pharmaceuticals (Bactoban Nasal (calcium mupirocin))

Societa Italiana Medicinali Scandicci 

1. Societa Italiana Medicinali Scandicci (Site Inspection)

SOL Pharmaceuticals Limited

1. SOL Pharmaceuticals Limited (Site Inspection)

St. Anthony Memorial Health Center

1. St. Anthony Memorial Health Center (Site Inspection)

Supergen, Inc.

1. SuperGen, Inc. (Nipent® (pentostatin) for Injection)
    
2. SuperGen, Inc. (Rubitecan)
    
   
3. SuperGen, Inc. (Nipent® (pentostatin) for Injection)

Synsorb Biotech, Inc.

1. Synsorb Biotech Inc. (SYNSORB PK)

Takeda Pharmaceuticals North America, Inc.

1. Takeda Pharmaceuticals North America, Inc. (Rozerem^TM (ramelteon) Tablets)
    
2. Takeda Pharmaceuticals North America, Inc. (Actos (pioglitazone hydrochloride) Tablets)

TAP Holdings/Pharmaceutical Products, Inc.

1. TAP Pharmaceutical Products, Inc. (Prevacid (lansoprazole) Delayed Release Capsules)
    
2. TAP Pharmaceutical Products, Inc. (Uprima (apomorphine HCl tablets) sublingual )
    
   
3. TAP Holdings Inc. (Prevacid (lansoprazole) Delayed Release Capsules )

ThermoLife International

1. ThermoLife International (Lipodryl II)

Tianjin Xin Xin Pharmaceutical Corporation

1. Tianjin Xin Xin Pharmaceutical Corporation (Site Inspection

Tomita Pharmaceutical Co., Ltd

1. Tomita Pharmaceutical Co., Ltd (Site Inspection)

Travanti Pharma, Inc.

1. Travanti Pharma, Inc. (Clinical Investigation)

Underwood, Hollis J.C. M.D.

1. Hollis J.C. Underwood, M.D. (BMIS Inspection)

Unimed Pharmaceuticals

1. Unimed Pharmaceuticals, Inc. (Anadrol-50 (oxymetholone) tablets)

United Therapeutics Corporation

1. United Therapeutics Corporation (Remodulin® (treprostinil sodium) Injection)

University of Illinois

1. University Of Illinois (Clinical Study)

University of Texas Southwestern Medical Center

1. University of Texas Southwestern Medical Center (BMIS Inspection)

Utah Valley Institute of Cystic Fibrosis

1. Utah Valley Institute of Cystic Fibrosis (Clinical Study)

VaxGen, Inc.

1. VaxGen, Inc. (Anthrax Vaccine)

Vivus Inc.

1. VIVUS, Inc. (MUSE (alprostadil) Urethral Suppository)
    
2. Vivus Inc. (MUSE (alprostadil) urethral suppository)

Watson Laboratories, Inc.

1. Watson Pharmaceuticals, Inc. (Ferrlecit (sodium ferric gluconate complex in sucrose injection))
    
2. Watson Laboratories, Inc. (Norco (hydrocodone bitartrate and acetaminophen tablets, USP))

WellSpring Pharmaceutical Corporation

1. WellSpring Pharmaceutical Corporation (Dyrenium® (triamterene) Capsules)

WIL Research Laboratories Inc.

1. WIL Research Laboratories Inc. (Site Inspection)

Wockhardt Ltd.

1. Wockhardt Ltd. (Site Inspection)

Women's Capital Corporation

1. Women's Capital Corporation (Plan B (levonorgestrel) Tablets, 0.75 mg)

Wyeth Pharmaceuticals, Inc./Wyeth-Ayerst Laboratories/Wyeth-Ayerst Research

1. Wyeth Pharmaceuticals, Inc. (Effexor XR^© (venlafaxine HCI) Tablets)
    
2. Wyeth Pharmaceuticals (Effexor, Effexor XR)
    
3. Wyeth-Ayerst Laboratories (Suprax (cefixime) Oral)
    
4. Wyeth-Ayerst (Protonix Injection and Delayed-Release Tablets)
    
   
5. Wyeth-Ayerst (Effexor XR (venlafaxine) Extended Release Capsules)
    
   
6. Wyeth-Ayerst Research (Sonata (zaleplon) Capsules)

Xanodyne Pharmacal, Inc.

1. Xanodyne Pharmacal, Inc. (Methotrexate, Leucovorin, Amicar)

Xcel Pharmaceuticals

1. Xcel Pharmaceuticals (Migranal (Dihydroergotamine Mesylate) Nasal Spray & D.H.E. 45 Injection)

Xinjiang Pharmaceutical Factory

1. Xinjiang Pharmaceutical Factory (Site Inspection)

Yung Shin Pharm. Inc. Col, Ltd.

1. Yung Shin Pharm. Inc. Col, Ltd. (Site Inspection)

Zaharowitz, Herman  M.D.

1. Herman Zaharowitz, M.D. (Clinical Investigation)

Zila Pharmaceuticals, Inc.

1. Zila Pharmaceuticals, Inc. (Peridex® (chlorhexidine gluconate 0.12%) Oral Rinse)

ZymoGenetics, Inc.

1. ZymoGenetics, Inc. (Recothrom™ (Thrombin, Topical (Recombinant)))