FDA Warning Letters/Notice of Violation 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 (Depakote (divalproex sodium))
    
2. Abbott Laboratories (HUMIRA (adalimumab) Injection)
    
3. Abbott Laboratories (Survanta®(beractant) intratracheal suspension)
    
4. Abbott Laboratories (Kaletra (lopinavir/ritonavir) Capsules and Oral Suspension)
    
5. Abbott Laboratories (Norvir (ritonavir capsules) Soft Gelatin)
    
6. 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)
    
3. Actelion Pharmaceuticals US, Inc. (Tracleer (bosentan) Tablets)

Adamis Pharmaceuticals

1. Adamis Pharmaceuticals (Marketing of unapproved new drugs)

Adolor Corporation

1. Adolor Corporation (ENTEREG® (alvimopan) Capsules)

Aerosol Science Laboratories, Inc.

1. Aerosol Science Laboratories, Inc. (SINUS SCIENCE Aerosol Medication Delivery System)

Alaven Pharmaceutical LLC

1. Alaven Pharmaceutical LLC (Rowasa® (mesalamine) Rectal Suspension Enema)

Alcon Research/Alcon Laboratories

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

Aliachem A.S.

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

Alkermes, Inc.

1. Alkermes, Inc. (VIVITROL (naltrexone for extended-release injectable suspension))

Allergan, Inc.

1. Allergan, Inc. (Lumigan®(bimatoprost ophthalmic solution))
    
2. Allergan, Inc. (Acuvail^TM (ketorolac tromethamine ophthalmic solution) 0.45%)
    
3. Allergan, Inc. (LATISSE^TM (bimatoprost ophthalmic solution) 0.03%)
    
4. Allergan, Inc. (ACZONE® (dapsone) Gel, 5%)
    
5. Allergan, Inc. (ACULAR LS® (ketorolac tromethamine ophthalmic solution) 0.4%)
    
6. Allergan, Inc. (Lumigan (bimatoprost ophthalmic solution) 0.03%)
    
7. Allergan, Inc. (Lumigan (bimatoprost ophthalmic solution) 0.03%)
    
   
8. Allergan, Inc. (Alphagan (brimonidine tartrate ophthalmic solution) 0.2%)
    
   
9. Allergan Inc. (Azelex (Azelaic Acid) 20% Cream)
    
   
10. Allergan, Inc. (Alocril (nedocromil sodium ophthalmic solution), 2%)

Allergy, Asthma & Immunology Associates of Terra Haute

1. Allergy, Asthma & Immunology Associates of Terra Haute (Clinical Investigation)

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))

AMAG Pharmaceuticals, Inc.

1. AMAG Pharmaceuticals, Inc. (NDA 22180 Feraheme (ferumoxytol) Injection for IV use)
    
2. AMAG Pharmaceuticals, Inc. (GastroMARK® (ferumoxsil, oral suspension) & Feraheme™ (ferumoxytol) Injection For Intravenous (IV) use)

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. (Vectibix® (panitumumab) Solution for Intravenous Infusion)
    
2. Amgen, Inc. (SENSIPAR® (cinacalcet HCl) Tablets)
    
3. Amgen, Inc. (Enbrels (etanercept))

Amrita Aromatherapy, Inc.

1. Amrita Aromatherapy, Inc. (Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus)

Amylin Pharmaceuticals, Inc.

1. Amylin Pharmaceuticals, Inc. (Byetta® (exenatide) injection)

Antibioticos do Brasil Uda

1. Antibioticos do Brasil Uda (CGMP/Adulterated)

AOI Pharmaceuticals, Inc.

1. AOI Pharmaceuticals, Inc./Keryx Biopharmaceuticals, Inc. (KRX-0401 (perifosine))

Apotex Inc.

1. Apotex Inc. (Inspection of pharmaceutical manufacturing facility)

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

Aton Pharma

1. Aton Pharma, a Division of Valeant Pharmaceuticals North America LLC (Mephyton (phytonadione) Vitamin K1 Tablets)

Aurobindo Pharma Limited

1. Aurobindo Pharma Limited (Regulations for Finished Pharmaceuticals)

Auxilium Pharmaceuticals, Inc.

1. Auxilium Pharmaceuticals, Inc. (XIAFLEX™ (collagenase clostridium histolyticum) for injection, for intralesional use)

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)

Axcan Pharma, Inc.

1. Axcan Pharma, Inc. (Photofrin® (porfimer sodium) for injection)

Axium Healthcare Pharmacy

1. Axium Healthcare Pharmacy (Domperidone)

Barr Research, Inc.

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

Baumann Cosmetic and Research Institute

1. Baumann Cosmetic and Research Institute (Dysport (abobotulinumtoxinA) for Injection)

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)

Bay Regional Medical Center

1. Bay Regional Medical Center (Institutional Review Board (IRB) Inspection)

Bayer Corporation/Bayer HealthCare Pharmaeceuticals, Inc.

1. Bayer HealthCare Pharmaceuticals, Inc. (Mirena® (levonorgestrel-releasing intrauterine system))
    
2. Bayer Healthcare Pharmaceuticals, Inc. (LEVITRA; YAZ; Mirena)
    
3. Bayer HealthCare L.L.C. (Bayer Aspirin with Hearth Advantage)
    
4. Bayer HealthCare L.L.C. (Bayer Women's Low Dose Aspirin + Calcium)
    
5. Bayer HealthCare Pharmaceuticals, Inc. (YAZ® (drospirenone and ethinyl estradiol) Tablets)
    
6. Bayer Pharmaceuticals Corporation (Levitra° (vardenafil HCl) Tablets)
    
7. Bayer Corporation (Avelox (moxifloxacin HCL))
    
   
8. Bayer Corporation (Vardenafil)
    
   
9. 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. (TYSABRI® (natalizumab) injection for intravenous use)
    
2. 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 USA LLC  (Sotradecol™ (sodium tetradecyl sulfate injection))
    
2. 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/Roxane, Inc.

1. Boehringer Ingelheim Pharmaceuticals, Inc. (Spiriva HandiHaler; Flomax Capsules; Mirapex Tablets)
    
2. Boehringer Ingelheim Roxane, Inc. (Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg)
    
3. Boehringer-Ingelheim (Mirapex® (pramipexole dihydrochloride))
    
4. Boehringer Ingelheim Pharmaceuticals, Inc. (Spiriva® Handihaler® (tiotropium bromide inhalation powder))
    
5. Boehringer Ingelheim Pharmaceuticals, Inc. (Aggrenox® (aspirin/extended-release dipyridamole) Capsules)
    
6. Boehringer Ingelheim Pharmaceuticals, Inc. (Viramune (nevirapine) Tablets and Viramune (nevirapine) Oral Suspension)
    
7. Boehringer Ingelheim Pharmaceuticals, Inc. (Atrovent (ipratropium bromide) Inhalation Aerosol and Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol)
    
8. Boehringer Ingelheim Pharmaceuticals, Inc. (Viramune (nevirapine) Tablets and Oral Suspension)

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)

Brookwood Medical Center

1. Brookwood Medical Center (Institutional Review Board)

Cadila Healthcare Limited

1. Cadila Healthcare Limited (Regulations for Finished Pharmaceuticals)

CanaRx Services, Inc.

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

Cape Drugs

1. Cape Drugs (Domperidone)

Capstone Clinical Trials, Inc.

1. Capstone Clinical Trials, Inc. (Clinical Investigation)

Carter Wallace

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

Celgene Corporation

1. Celgene Corporation (Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound))
    
2. Celgene Corporation (Thalomid (thalidomide) Capsules)

CEL-SCI Corporation

1. CEL-SCI Corporation (Multikine (Leukocyte Interleukin) Injection)

Central Pennsylvania Clinical Research

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

Centocor, Inc.

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

Cephalon, Inc.

1. Cephalon, Inc. (Trisenox (arsenic trioxide) injection)
    
2. Cephalon, Inc. (Treanda® (bendamustine hydrochloride) for Injection)
    
3. Cephalon, Inc. (Provigil® (modafinil) Tablets [C-IV])
    
4. Cephalon Inc. (Provigil (modafinil) Tablets)

Changzhou SPL Company, Ltd

1. Changzhou SPL Company, Ltd (Site Inspection)

Choksi Laboratories, Ltd.

1. Choksi Laboratories, Ltd. (Violations of Current Good Manufacturing Practice (CGMP) regulations)

CHRISTUS Schumpert Health System

1. CHRISTUS Schumpert Health System (Bioresearch Monitoring Program/IRB)

CIBA Vision

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

Claris Lifesciences Limited

1. Claris Lifesciences Limited (Violations of Current Good Manufacturing Practice (CGMP) Regulations)

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 IRB, LLC (Clinical Investigation)
    
2. Coast Institutional Review Board (Site Inspection)

Colleganex Pharmaceuticals, Inc.

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

Columbia University Medical Center RDRC

1. Columbia University Medical Center RDRC (Radioactive Drug Research Committee (RDRC))

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%)

CP Pharmaceuticals, Ltd.

1. CP Pharmaceuticals, Ltd. (Violations of Current Good Manufacturing Practice (CGMP) Regulations)

Corixa Corporation

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

Cornerstone Therapeutics, Inc.

1. Cornerstone Therapeutics, Inc. (Zyflo CR® (zileuton) extended-release tablets)
    
2. Cornerstone Therapeutics, Inc. (Spectracef® (cefditoren pivoxil) Tablets)

Coulston Foundation

1. Coulston Foundation (Site Inspection)

Covenant Healthcare

1. Covenant Healthcare IRB (Institutional Review Board (IRB))

Craig M. Buettner, M.D.

1. Craig M. Buettner, M.D. (Clinical Investigation)

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)

Cumberland Pharmaceuticals, Inc.

1. Cumberland Pharmaceuticals/Lamar L. Snow, M.D. (Clinical Investigation)
    
2. Cumberland Pharmaceuticals, Inc. (ACETADOTE® (acetylcysteine) Injection)

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)

DENTSPLY Pharmaceutical

1. DENTSPLY Pharmaceutical  (NDA 21451 Oraqix (lidocaine and prilocaine periodontal gel) 2.5%/2.5%)

Dexcel Pharma Technologies Ltd.

1. Dexcel Pharma Technologies Ltd. (PerioChip® (chlorhexidine gluconate) 2.5 mg)

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 %)

Dr. Reddy's Laboratories Limited

1. Dr. Reddy's Laboratories, Inc. (Fondaparinux Sodium Solution for subcutaneous injection)
    
2. Dr. Reddy's Laboratories Limited (Manufacture of APIs)

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))

Eisai, Inc.

1. Eisai, Inc. (NDA 20-637 GLIADEL®)
    
2. Eisai, Inc. (Dacogen® (decitabine))

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 (Adcirca^TM (tadalafil) Tablets)
    
2. Eli Lilly and Company (Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use)
    
3. Eli Lilly and Company (Cymbalta Capsules; EVISTA Tablet, and Gemzar for Injection)
    
4. Eli Lilly and Company (CYMBALTA© (duloxetine hydrochloride) Delayed-release Capsules)
    
5. Eli Lilly and Company (Alimta® pemetrexed for injection)
    
6. Eli Lilly and Company (Strattera (atomoxetine HCl))
    
7. Eli Lilly and Company (Sarafem (fluoxetine HCI) Tablets)
    
   
8. Eli Lilly and Company (Evista (raloxifene HCl) Tablets)
    
   
9. Eli Lilly and Company (IND Promotion)
    
   
10. 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))

Ephraim McDowell Regional Medical Center

1. Ephraim McDowell Regional Medical Center (Institutional Review Board)

EUSA Pharma (USA), Inc.

1. EUSA Pharma (USA), Inc. (ProstaScint Kit (Capromab Pendetide))

Evangeline G. Gonzalez, M.D.

1. BMIS Inspection (Warning Letter)

Expedite-Rx

1. Expedite-Rx (Prescription Drug Importation)

Family Health Care of Hendersonville

1. Family Health Care of Hendersonville (Clinical Investigation)

Feel Good Natural Health Stores

1. Feel Good Natural Health Stores (H1N1 Flu Virus-Related Products)

FIDIA s.p.a.

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

Forest Laboratories, Inc

1. Forest Laboratories, Inc. (Savella (milnacipran HCl) Tablets)
    
2. Forest Laboratories, Inc. (Bystolic® (nebivolol) Tablets)
    
3. Forest Laboratories, Inc. (Celexa (citalopram HBr))
    
4. 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) 

G. Pohl-Boskamp GmbH & Co. KG

1. G. Pohl-Boskamp GmbH & Co. KG c/o Arbor Pharmaceuticals, Inc (Nitrolingual Pumpspray (nitroglycerin lingual spray))

Galderma Laboratories, L.P.

1. Galderma Laboratories (Tri-Luma® Cream)
    
2. Galderma Laboratories (Differin (adapalene gel) Gel, 0.1%)

Galyna/Ivan Podornikova

1. Galyna/Ivan Podornikova (Internet Marketing of Unapproved and Misbranded Drugs)

Gamucci America

1. Gamucci America (Products marketed under "Gamucci" name)

GE Healthcare

1. GE Healthcare (Visipaque ^TM (iodixanol) Injection)

GelTex Pharmaceuticals

1. GelTex Pharmaceuticals (Renagel Capsules/Tablets)

Gemeindezentrum

1. Gemeindezentrum (Site Inspection)

Gene Logic, Inc.

1. Gene Logic, Inc. (BMIS Inspection)

Genetech, Inc.

1. Genetech, Inc. (BONIVA (ibandronate sodium) Tablets)
    
2. Genentech, Inc. (Rituxan® (Rituximab) Injection for Intravenous Use)
    
3. Genentech, Inc. (Avastin; LUCENTISTM; RITUXAN®; Xolair®; HERCEPTIN®; Pulmozyme®)
    
4. Genentech (Nutropin)
    
5. 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 (Letairis^TM (ambrisentan) Tablets)
    
2. Gilead Sciences (Viread® (tenofovir disoproxil fumarate) Tablets)
    
3. Gilead Sciences (Viread® (tenofovir disoproxil fumarate) Tablets)

GlaxoSmithKline/Glaxo Wellcome

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

Glenmark Generics, Inc.

1. Glenmark Generics, Inc. (Nitroglycerin Tablets, 0.3 mg, 0.4 mg, and 0.6 mg)

Granules India Limited

1. Granules India Limited (Site Inspection)

Greater Miami Skin and Laser Center

1. Greater Miami Skin and Laser Center (Clinical Investigation)

Guilford Pharmaceuticals, Inc.

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

Haw Par Healthcare Limited

1. Haw Par Healthcare Limited (TIGER BALM® Pain Relieving PATCH (Tiger Balm))

Hemispherx Biopharma, Inc.

1. Hemispherx Biopharma, Inc. (Ampligen)

Herbtech

1. Herbtech (Ephedra or Ma Huang)

Herron, Jerry M. M.D.

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

Heyltex Corporation

1. Heyltex Corporation (IND Inspection)

Hill Pharmaceuticals, Inc.

1. Hill Pharmaceuticals, Inc. (NDA 19452 Derma-Smoothe/FS (flucinolone acetonide) Topical Oil, 0.01% (Body Oil))

Hoffmann-La Roche

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

Homeopathy for Health

1. Homeopathy for Health (H1N1 Flu Virus-Related Products)

Hospital Municipal de San Juan

1. Hospital Municipal de San Juan (Clinical Investigation)

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)

ICON Clinical Research

1. ICON Clinical Research (Contract monitoring organization (CRO))

Indevus Pharmaceuticals, Inc.

1. Indevus Pharmaceuticals, Inc. (Sanctura® (trospium chloride) 20 mg Tablets)

Inspire Pharmaceuticals, Inc.

1. Inspire Pharmaceuticals, Inc. (AzaSite (azithromycin ophthalmic solution) 1%)

Institute for Advanced Clinical Research

1. Institute for Advanced Clinical Research (Clinical Study)

InterMune, Inc.

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

Iroko Pharmaceuticals, LLC

1. Iroko Pharmaceuticals, LLC (Indocin (indomethacin) Oral Suspension)

ISTA Pharmaceuticals, Inc.

1. ISTA Pharmaceuticals (Bromday (bromfenac ophthalmic solution) 0.09%)
    
2. ISTA Pharmaceuticals, Inc. (XIBROM™ (bromfenac ophthalmic solution) 0.09%)
    
3. 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)

Jazz Pharmaceuticals

1. Jazz Pharmaceuticals (Luvox CR® (fluvoxamine maleate) Extended-Release Capsules)

Jenahexal Pharm GmbH

1. Jenahexal Pharm GmbH (Manufacture of Finished Pharmaceuticals)

Pharmaceutical Company Jelfa SA

1. Pharmaceutical Company Jelfa SA (Regulations for Finished Pharmaceuticals)

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

1. Johnson & Johnson, Consumer & Personal Products Worldwide (ERTACZO™ (sertaconazole nitrate) Cream, 2%)
    
2. Johnson & Johnson Pharmaceutical Research & Development, LLC (Bioresearch Monitoring Program/IRB)
    
3. Johnson & Johnson (ULTRAM® ER (tramadol HCl) Extended-Release Tablets)
    
4. Johnson & Johnson Pharmaceutical Services, L.L.C. (PREZISTA™ (darunavir) Tablet)
    
5. Johnson & Johnson (CONCERTA® (methylphenidate HCl) Extended-release Tablets [CII] )
    
6. Johnson & Johnson Consumer Companies, Inc. (Retin-A Micro (tretinoin gel) microsphere, 0.1%)
    
7. 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)

Keryx Biopharmaceuticals, Inc.

1. AOI Pharmaceuticals, Inc./Keryx Biopharmaceuticals, Inc. (KRX-0401 (perifosine))

King Pharmaceuticals, Inc.

1. King Pharmaceuticals, Inc. (EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules)
    
2. King Pharmaceuticals, Inc. (Avinza® (morphine sulfate extended-release capsules) CII)
    
3. King Pharmaceuticals (Altace (ramipril) Capsules)

Klinge Chemicals Unlimited

1. Klinge Chemicals Unlimited (Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs)

Knoll Pharmaceutical

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

Konec, Inc.

1. Konec, Inc. (Nitroglycerin Tablets, 0.3 mg, 0.4 mg, and 0.6 mg)

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%)

Kyowa Hakko Kogyo Co., Ltd.

1. Kyowa Hakko Kogyo Co., Ltd. (Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs)

Laboratoire Atlas, Inc.

1. Laboratoire Atlas, Inc. (Human Drug Finished Product)

Lantheus Medical Imaging, Inc.

1. Lantheus Medical Imaging, Inc. (Technelite (Technetium Tc 99m Generator))

Lehigh Valley Technologies, Inc.

1. Lehigh Valley Technologies, Inc. (Codeine Sulfate Tablets, 30 mg & 60 mg)

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)

Macco Organiques, Inc.

1. Macco Organiques, Inc. (Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs)

Mallinckrodt, Inc.

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

Mark F. Gordon, M.D.

1. Mark F. Gordon, M.D. (Clinical Investigation)

Massachusetts General Hospital

1. Massachusetts General Hospital (Clinical Investigation)

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)

Meda Pharmaceuticals, Inc.

1. Meda Pharmaceuticals, Inc. (ASTELIN®(azelastine hydrochloride) Nasal Spray)

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. (Januviatm; Propecia; Singular; Emend)
    
2. Merck & Co. Inc. (Vioxx (rofecoxib) tablets)
    
   
3. Merck & Co. Inc. (Cancidas (caspofungin acetate))
    
   
4. Merck & Co. Inc. (Fosamax (alendronate sodium tablets))
    
   
5. Merck & Co. Inc. (Crixivan (indinavir sulfate) tablets)
    
   
6. Merck & Co. Inc. (Fosamax (alendronate sodium) and Vioxx (rofecoxib)

MGI Pharma, Inc.

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

MGS Representations

1. MGS Representations (All Soapopular hand sanitizers)

Miami Institute for Medical Research

1. Miami Institute for Medical Research (Clinical Investigation)

Moehs Iberica, S.L.

1. Moehs Iberica, S.L. (Manufacture of APIs)

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)

Mutual Pharmaceutical Company, Inc.

1. Mutual Pharmaceutical Company, Inc. (Colcrys (colchicine, USP) tablets for Oral use)

Nabi

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

Nanjing Maohai Biotech Co.

1. Nanjing Maohai Biotech Co. (Manufacture of Drug)

Nephrx

1. Nephrx (Calcitriol Injection 1 mcg/mL)

NeurogesX, Inc.

1. NeurogesX, Inc. (Qutenza (capsaicin) 8% patch)

Neurological Associates of Albany

1. Neurological Associates of Albany (Clinical Investigation)

New Mexico Veteran’s Administration Health Care System

1. New Mexico Veteran’s Administration Health Care System (Clinical Investigation)

Niagara Pharmaceuticals Inc.

1. Niagara Pharmaceuticals Inc. (Site Inspection)

Ningbo Smart Pharmaceutical Co. Ltd.

1. Ningbo Smart Pharmaceutical Co. Ltd. (Current Good Manufacturing Practice (CGMP) for the manufacture of APIs)

Noli R Zosa, M.D.

1. Noli R Zosa, M.D. (Clinical Investigation)

North American Science Associates, Inc.

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

Northeast General Pharmaceutical Factory

1. Northeast General Pharmaceutical Factory (Site Inspection)

Novalar Pharmaceuticals, Inc.

1. Novalar Pharmaceuticals, Inc. (OraVerse (phentolamine mesylate) Injection)

Novartis Ophthalmics

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

Novartis Pharmaceuticals/Oncology Corporation

1. Novartis Oncology (Gleevec (imatinib mesylate) tablets for oral use)
    
2. Novartis International AG (Manufacture of Finished Pharmaceuticals)
    
3. Novartis Pharmaceuticals Corporation (Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules Cll)
    
4. Novartis Pharmaceuticals (Tasigna (nilotinib) Capsules)
    
5. Novartis Pharmaceutical (Femara, Diovan, Exforge, Exjade, and Gleevec)
    
6. Novartis Pharmaceuticals (Focalin XR® (dexmethylphenidate hydrochloride) extended-release capsules CII)
    
7. Novartis Pharmaceuticals (Trileptale (oxcarbazepine) Tablets and Oral Suspension)
    
8. Novartis Pharmaceuticals (Exelon® (rivastigmine tartrate) Capsules and Oral Solution)
    
9. Novartis Pharmaceuticals (Diovan® (valsartan) Tablets)
    
10. Novartis Pharmaceuticals (Lamisil® (terbinafine hydrochloride) 250 mg Tablets)
     
11. Novartis Pharmaceuticals (Transderm Scop (scopolamine) Transdermal Therapeutic System)
     
12. Novartis Pharmaceuticals (Comtan® (entacapone) Tablets)
     
13. Novartis Pharmaceuticals (Transderm Scop (scopolamine) Transdermal Therapeutic System)
     
14. Novartis Pharmaceuticals (Miacalcin Nasal Spray and Exelon Capsules)
     
15. Novartis Pharmaceuticals Corporation (Femara (letrozole) Tablets
     
16. Novartis Pharmaceuticals Corporation (Neoral Soft Gelatin Capsules, Neoral Oral Solution)
     
17. Novartis Pharmaceuticals Corporation (Diovan (valsartan) Capsules)
     
18. Novartis Pharmaceuticals Corporation (Lescol (fluvastatin sodium) Capsules)

Noven Pharmaceuticals, Inc.

1. Noven Pharmaceuticals, Inc. (Pexeva (paroxetine mesylate) Tablets)

Novo Nordisk Pharmaceuticals

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

Nozin LLC

1. Nozin LLC (Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus)

Nycomed US, Inc.

1. Nycomed US, Inc. (Solaraze (diclofenac sodium) Gel, 3%)

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)

onlinepharmacyy.com

1. onlinepharmacyy.com (Internet Marketing of Unapproved and Misbranded Drugs)

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)

Otsuka Pharmaceutical Development and Commercialization, Inc.

1. Otsuka Pharmaceutical Development and Commercialization, Inc. (Busulfex (busulfan) Injection)

Ozelle Pharmaceuticals

1. Ozelle Pharmaceuticals (Anvirzel ^TM)

Paddock Laboratories, Inc.

1. Paddock Laboratories, Inc. (Morphine Sulfate Concentrate Oral Solution 20 mg/ml)

Palatin Technologies, Inc.

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

Palm Beach Gardens Medical Center

1. Palm Beach Gardens Medical Center (Clinical Investigation)

Pedinol Pharmacal, Inc.

1. Pedinol Pharmacal, Inc. (Nalfon® (fenoprofen calcium capsules) 200 mg and 400 mg)

Pfizer Inc.

1. Pfizer, Inc. (Chantix (varenicline) Tablets, NDA 021540 Caduet (amlodipine besylate/ atorvastatin calcium) Tablets, Norvasc (amlodipine besylate) Tablets)
    
2. Pfizer, Inc. (Sponsor Investigation)
    
3. Pfizer, Inc. (AROMASIN; CADUET; CHANTIX; Detrol LA; LYRICA; CELEBREX)
    
4. Pfizer, Inc. (Viagra® (sildenafil citrate) Tablets)
    
5. Pfizer, Inc. (Zoloft® (sertraline HCl) Tablets)
    
6. Pfizer, Inc. (Zyrtec® (cetirizine HCl) Tablets, Syrup, and Chewable Tablets)
    
7. Pfizer, Inc. (Celebrex & Bextra)
    
8. Pfizer, Inc. (Viagra® (sildenafil citrate) Tablets)
    
9. Pfizer, Inc. (Zyrtec-D 12 Hour® (cetirizine HC15 mg/pseudoephedrine HCl 120 mg) Extended Release Tablets)
    
10. Pfizer, Inc. (Camptosar® (irinotecan hydrochloride injection))
     
11. Pfizer Inc. (Covera-HS® (verapamil hydrochloride))
     
12. Pfizer Inc. (Geodon (ziprasidone HCI))
     
13. Pfizer Inc. (Lipitor (atorvastatin calcium) Tablets)
     
14. Pfizer, Inc. (Neurontin® (gabapentin))
     
15. Pfizer, Inc. (Zyrtec (cetirizine HCl) Tablets)
    
    
16. Pfizer Pharmaceuticals (Lipitor (atorvastatin calcium) Tablets)
     
    
17. Pfizer Pharmaceuticals (Neurontin (gabapentin))
     
    
18. Pfizer Pharmaceuticals (Estrostep (norethindrone acetate and ethinyl estradiol) Tablets)
     
    
19. Pfizer Pharmaceuticals (Zithromax (azithromycin for oral suspension))
     
    
20. 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 and Gamble (VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C)
    
2. Procter & Gamble (Actonel (risedronate sodium tablets))

Professional Clinical Research

1. Professional Clinical Research (Clinical Investigation)

Psypharma Clinical Research, Inc.

1. Psypharma Clinical Research, Inc. (Bioresearch Monitoring Program/IRB)

Protherics, Inc.

1. Protherics, Inc. (Voraxaze^TM (glucarpidase))

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)

Q-Based Solutions, Inc.

1. Q-Based Solutions, Inc. (Products Related to the H1N1 Flu Virus)

Qualiphar n.v.

1. Qualiphar n.v. (Violations of Current Good Manufacturing Practice (CGMP) regulations)

Quinones, Manuel J. M.D.

1. Manuel J. Quinones, M.D. (Clinical Investigation)

Radiant Research

1. Radiant Research (Clinical Study)

Ranbaxy Laboratories Limited

1. Ranbaxy Laboratories Limited (Dewas, India Site Inspection)
    
2. Ranbaxy Laboratories Limited (Batamandi, India Site Inspection)
    
3. 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)

Robert Deitz, M.D.

1. Robert Deitz, M.D. (Clinical Investigation)

Roche Laboratories, Inc.

1. Roche Laboratories (Tasmar (tolcapone) Tablets)

Rochester General Hospital 

1. Rochester General Hospital (Clinical Study)

Romark Laboratories, L.C.

1. Romark Laboratories, L.C. (Alinia® (nitazoxanide) Tablets and (nitazoxanide) for Oral Suspension)

Salix Pharmaceuticals, Inc.

1. Salix Pharmaceuticals, Inc. (METOZOLV™ ODT (metoclopramide hydrochloride) orally disintegrating tablets)

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 Deutschland GmbH (Significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals)
    
2. Sanofi-Aventis U.S. Inc. (Eligard 45mg (leuprolide acetate for injectable suspension))
    
3. Sanofi-Aventis U.S. LLC (BenzaClin® (clindamycin 1% - benzoyl peroxide 5%) gel)
    
4. Sanofi-Aventis U.S. LLC (UROXATRAL® (alfuzosin HCl) Extended-Release Tablets for Oral use)
    
5. Sanofi-Aventis (Taxotere® (docetaxel) Injection Concentrate, Intravenous Infusion (IV))
    
6. 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%)

Sarcoma Oncology Center

1. Sarcoma Oncology Center (Clinical Investigation)

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, Inc. (Lunesta® (eszopiclone) Tablets)
    
2. 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)

Shionogi USA, Inc.

1. Shionogi USA, Inc. (Cedax® (ceftibuten capsules and ceftibuten for oral suspension))

Shire Laboratories, Inc./Shire Development, Inc.

1. Shire Pharmaceuticals, Inc. (Vyvanse® (lisdexamfetamine dimesylate) Capsules, CII)
    
2. Shire Development, Inc. (Intuniv™ (guanfacine) extended-release tablets)
    
3. Shire Development, Inc. (LIALDA® (mesalamine) Delayed Release Tablets)
    
4. Shire Development, Inc. (Fosrenol® (lanthanum carbonate hydrate) Chewable Tablets)
    
5. Shire Development, Inc. (Adderall XR® Capsules)
    
6. Shire Development, Inc. (Fosrenol® (lanthanum carbonate))
    
7. Shire Pharmaceutical Development, Inc. (ProAmatine (midodrine hydrochloride) Tablets)
    
   
8. Shire Laboratories, Inc. (Fareston (toremifene citrate))

Sichuan Pharmaceutical Co., Ltd.

1. Sichuan Pharmaceutical Co., Ltd. (Manufacture of APIs)

Sigma-Tau Pharmaceuticals Inc.

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

Similasan AG

1. Similasan AG (Site Inspection)

Sirion Therapeutics, Inc.

1. Sirion Therapeutics, Inc. (Durezol™ (difluprednate ophthalmic emulsion) 0.05%)

Sitek Research Laboratories

1. Sitek Research Laboratories (BMIS Inspection)

SkyePharma

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

Slate Pharmaceuticals

1. Slate Pharmaceuticals (Testopel® Pellets (testosterone), CIII)

SmithKline Beecham Pharmaceuticals

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

SNBL USA, Ltd.

1. SNBL USA, Ltd. (Laboratory Investigation)

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)

Sunovion Pharmaceuticals, Inc.

1. Sunovion Pharmaceuticals, Inc. (Latuda (lurasidone HCl) Tablets)

Supergen, Inc.

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

Synbiotics Limited

1. Synbiotics Limited c/o Ambalal Sarabhai Enterprises (Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs)

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 )

Taro Pharmaceuticals U.S.A., Inc.

1. Taro Pharmaceuticals USA, Inc. (Ovide (malathion) lotion, 0.5%)
    
2. Taro Pharmaceuticals U.S.A., Inc. (Inspection of Manufacturing Facility)

Tercica Inc.

1. Tercica Inc. (INCRELEX® (mecasermin [rDNA origin] injection))

ThermoLife International

1. ThermoLife International (Lipodryl II)

Three Rivers Pharmaceuticals, LLC

1. Three Rivers Pharmaceuticals, LLC (INFERGEN® (interferon alfacon-1) injection for subcutaneous use)

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)

UCLA David Geffen School of Medicine

1. UCLA David Geffen School of Medicine (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)

Union Springs Pharmaceuticals, LLC

1. Union Springs Pharmaceuticals, LLC (Marketing of MyClyns Personal Protection Spray)

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)

Vanderveer Center

1. Vanderveer Center (Website contains false or misleading claims related to your Lipodissolve products)

VaxGen, Inc.

1. VaxGen, Inc. (Anthrax Vaccine)

Washington University of St. Louis

1. Washington University of St. Louis (Clinical Investigation)

Victory Pharma, Inc.

1. Victory Pharma, Inc. (Xodol (hydrocodone bitartrate and acetaminophen) tablets)

Vivus Inc.

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

Warner Chilcott (US), LLC

1. Warner Chilcott (US), LLC (Atelvia (risedronate sodium) Delayed-release Tablets)

Watson Laboratories, Inc.

1. Watson Pharmaceuticals, Inc. (GELNIQUE (oxybutynin chloride) 10% gel)
    
2. Watson Pharmaceuticals, Inc. (Ferrlecit (sodium ferric gluconate complex in sucrose injection))
    
3. 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)

Women’s Cancer Center of Nevada

1. Women’s Cancer Center of Nevada (Clinical Investigation)

www.naturesgift.com

1. www.naturesgift.com (Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus)

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

1. Wyeth Pharmaceuticals, Inc. (Premarin^® (conjugated estrogens tablets, USP))
    
2. Wyeth Pharmaceuticals, Inc. (Effexor XR^© (venlafaxine HCI) Tablets)
    
3. Wyeth Pharmaceuticals (Effexor, Effexor XR)
    
4. Wyeth-Ayerst Laboratories (Suprax (cefixime) Oral)
    
5. Wyeth-Ayerst (Protonix Injection and Delayed-Release Tablets)
    
   
6. Wyeth-Ayerst (Effexor XR (venlafaxine) Extended Release Capsules)
    
   
7. 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)

Yuki Gosei Kogyo Co., Ltd.

1. Yuki Gosei Kogyo Co., Ltd. (Deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs)

Yung Shin Pharm. Inc. Col, Ltd.

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

Yunnan Hande Bio-Tech Co., Ltd.

1. Yunnan Hande Bio-Tech Co., Ltd. (Active pharmaceutical ingredient (API) manufacturing facility)

Zaharowitz, Herman  M.D.

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

Zhejiang Casing Animal By-Products Co. Ltd.

1. Zhejiang Casing Animal By-Products Co. Ltd. (Manufacture of Drug)

Zila Pharmaceuticals, Inc.

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

ZymoGenetics, Inc.

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