Recently Published FDA Form 483s

Life Sera, Inc. [Marietta / United States of America]

Inspection End Date: July 28, 2003

FEI: 1076403

Location: MARIETTA, GEORGIA, United States of America

Investigators: Leslie W Gilbert, Megan K Robinson

Sparton Medical [Strongsville / United States of America]

Inspection End Date: July 28, 2003

FEI: 3003144120

Location: STRONGSVILLE, OHIO, United States of America

Investigators: Benjamin J Dastoli

Northern California Community Blood Bank [Eureka / United States of America]

Inspection End Date: July 25, 2003

FEI: 2970101

Location: EUREKA, CALIFORNIA, United States of America

Investigators: Laverne Puckett

Tri-State Analytical Laboratory LLC [Johnson City / United States of America]

Inspection End Date: July 25, 2003

FEI: 3003725044

Location: JOHNSON CITY, TENNESSEE, United States of America

Investigators: Edward H Maticka

Ossur Americas [Paulsboro / United States of America]

Inspection End Date: July 25, 2003

FEI: 2242474

Location: PAULSBORO, NEW JERSEY, United States of America

Investigators: Karen F Tomaziefski

Pfizer Animal Health [Kalamazoo / United States of America]

Inspection End Date: July 25, 2003

FEI: 1827031

Location: KALAMAZOO, MICHIGAN, United States of America

Investigators: William D Tingley

Slade Gorton & Co., Inc. [Fort Lauderdale / United States of America]

Inspection End Date: July 25, 2003

FEI: 3004092114

Location: FORT LAUDERDALE, FLORIDA, United States of America

Investigators: LT Prince D Brown

Actavis Laboratories FL, Inc. [Davie / United States of America]

Inspection End Date: July 25, 2003

FEI: 3003194604

Location: DAVIE, FLORIDA, United States of America

Investigators: Ana Delp Cintron, Ana P Barido

Cambridge Major Laboratories, Inc. [Germantown / United States of America]

Inspection End Date: July 24, 2003

FEI: 2126816

Location: GERMANTOWN, WISCONSIN, United States of America

Investigators: Dale A Nyberg

Science For Biomaterials [Lourdes / France]

Inspection End Date: July 24, 2003

FEI: 3004051158

Location: LOURDES, OCCITANIE, France

Investigators: Stephen D Eich

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC [Andover / United States of America]

Inspection End Date: July 24, 2003

FEI: 1222181

Location: ANDOVER, MASSACHUSETTS, United States of America

Investigators: Walter N Lange, Seth A Mailhot

Innovative Blood Resources [Saint Paul / United States of America]

Inspection End Date: July 24, 2003

FEI: 2170665

Location: SAINT PAUL, MINNESOTA, United States of America

Investigators: Kellie L Westerbuhr, Darlene L Krieger, Maryann Ruff

Dynasty, Inc [Oklahoma City / United States of America]

Inspection End Date: July 24, 2003

FEI: 1000116904

Location: OKLAHOMA CITY, OKLAHOMA, United States of America

Investigators: Betsy C Galliher

Sybronendo, Div of Ormco Corp [Redmond / United States of America]

Inspection End Date: July 24, 2003

FEI: 3019316

Location: REDMOND, WASHINGTON, United States of America

Investigators: Jinkee Mvila Binayug, Philip E Ake, Lori J Silverstein

La Roka Water [Cabo Caribe Barrio / Puerto Rico]

Inspection End Date: July 24, 2003

FEI: 3004066204

Location: CABO CARIBE BARRIO, PUERTO RICO, Puerto Rico

Investigators: Luis A Carrion

Ethypharm, Inc. [Laval / Canada]

Inspection End Date: July 24, 2003

FEI: 3003658674

Location: LAVAL, QUÉBEC, Canada

Investigators: George J Flynn, Katherine Szestypalow

Paceline Inc. [Monroe / United States of America]

Inspection End Date: July 24, 2003

FEI: 1000512203

Location: MONROE, NORTH CAROLINA, United States of America

Investigators: Claudette D Brooks

Lopez Gonzalez Santana Corporation [San Juan / Puerto Rico]

Inspection End Date: July 23, 2003

FEI: 2650148

Location: SAN JUAN, PUERTO RICO, Puerto Rico

Investigators: Jorge L Lajara

Deltex Medical Limited [Chichester / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: July 23, 2003

FEI: 1000637007

Location: CHICHESTER, ENGLAND, United Kingdom of Great Britain and Northern Ireland

Investigators: Carolyn E Barney

St. Joseph Hospital [Eureka / United States of America]

Inspection End Date: July 23, 2003

FEI: 2972637

Location: EUREKA, CALIFORNIA, United States of America

Investigators: Laverne Puckett

Biomat USA, Inc. [Boise / United States of America]

Inspection End Date: July 23, 2003

FEI: 3022159

Location: BOISE, IDAHO, United States of America

Investigators: Dennis R Hudson

SunOpta Grains and Foods, Inc. [Alexandria / United States of America]

Inspection End Date: July 23, 2003

FEI: 1000520242

Location: ALEXANDRIA, MINNESOTA, United States of America

Investigators: Melissa D Kalik

GEO Analytical, Inc. [Twinsburg / United States of America]

Inspection End Date: July 22, 2003

FEI: 3002732454

Location: TWINSBURG, OHIO, United States of America

Investigators: Frederick M Lochner

Aplicare Incorporated [Prichard / United States of America]

Inspection End Date: July 22, 2003

FEI: 1120159

Location: PRICHARD, WEST VIRGINIA, United States of America

Investigators: James W Leonette

Avantor Performance Materials, LLC [Phillipsburg / United States of America]

Inspection End Date: July 22, 2003

FEI: 2220077

Location: PHILLIPSBURG, NEW JERSEY, United States of America

Investigators: Emest F Bizjak

Momentive Specialty Chemicals [Demopolis / United States of America]

Inspection End Date: July 22, 2003

FEI: 1000143710

Location: DEMOPOLIS, ALABAMA, United States of America

Investigators: Marvin D Jones

Sklar Instruments [West Chester / United States of America]

Inspection End Date: July 22, 2003

FEI: 2523865

Location: WEST CHESTER, PENNSYLVANIA, United States of America

Investigators: Michael A Taylor, Donald W Myrick

Piyush Patel, M.D. FRCP [Mississauga / Canada]

Inspection End Date: July 22, 2003

FEI: 3003617746

Location: MISSISSAUGA, ONTARIO, Canada

Investigators: Allen F Hall, Michael F Skelly, PhD

Linde gas LLC [Tampa / United States of America]

Inspection End Date: July 21, 2003

FEI: 1030367

Location: TAMPA, FLORIDA, United States of America

Investigators: Paul L Figarole, Jr, Gerardo Z Vazquez

MERCK SERONO SPA [Modugno / Italy]

Inspection End Date: July 21, 2003

FEI: 3003581732

Location: MODUGNO, PUGLIA, Italy

Investigators: Dr. Barbara D Paul, PhD, Douglas C Kovacs

Singh, Sudeep M.D. [Fresno / United States of America]

Inspection End Date: July 18, 2003

FEI: 3003104075

Location: FRESNO, CALIFORNIA, United States of America

Investigators: Jeffrey W Shrifter, DPM

Unette Corporation [Randolph / United States of America]

Inspection End Date: July 18, 2003

FEI: 2210679

Location: RANDOLPH, NEW JERSEY, United States of America

Investigators: Helen B Ricalde

Biomat USA, Inc. [Las Vegas / United States of America]

Inspection End Date: July 18, 2003

FEI: 2976605

Location: LAS VEGAS, NEVADA, United States of America

Investigators: Shelley H Roberts, Anthony E Keller, RPh, Shelley H Beausoleil

Microtek Medical Inc [Columbus / United States of America]

Inspection End Date: July 18, 2003

FEI: 1043582

Location: COLUMBUS, MISSISSIPPI, United States of America

Investigators: Verlinda A Narcisse

Food Ingredients Resources Inc. [Farmingdale / United States of America]

Inspection End Date: July 18, 2003

FEI: 2433129

Location: FARMINGDALE, NEW YORK, United States of America

Investigators: Joseph Maselli

Carolina Medical Inc [Charlotte / United States of America]

Inspection End Date: July 18, 2003

FEI: 3003500867

Location: CHARLOTTE, NORTH CAROLINA, United States of America

Investigators: Tracy R Ball

Accutome Ultrasound, Inc. [Malvern / United States of America]

Inspection End Date: July 18, 2003

FEI: 3002951954

Location: MALVERN, PENNSYLVANIA, United States of America

Investigators: Ronald A Stokes

Ameri-Pac, Inc [Saint Joseph / United States of America]

Inspection End Date: July 18, 2003

FEI: 1932659

Location: SAINT JOSEPH, MISSOURI, United States of America

Investigators: Tamara J Genetti, Julie N Vosilus

Cardinal Health Manufacturing Services B.V. [Río Abajo / Puerto Rico]

Inspection End Date: July 18, 2003

FEI: 2650094

Location: RÍO ABAJO, PUERTO RICO, Puerto Rico

Investigators: Wanda J Torres

Monserrat Pharmaceuticals Inc. [Aguas Buenas / Puerto Rico]

Inspection End Date: July 18, 2003

FEI: 3004082470

Location: AGUAS BUENAS, PUERTO RICO, Puerto Rico

Investigators: Rebecca Parrilla

Par Pharmaceutical Companies, Inc. [Somerset / United States of America]

Inspection End Date: July 17, 2003

FEI: 3003563656

Location: SOMERSET, NEW JERSEY, United States of America

Investigators: Kristy A Zielny

Mayne Pharma (PR) Inc. [Maleza Baja / Puerto Rico]

Inspection End Date: July 17, 2003

FEI: 2650040

Location: MALEZA BAJA, PUERTO RICO, Puerto Rico

Investigators: Jose Acruz Gonzalez, Noreen Muñiz

Vascular Architects [Nashville / United States of America]

Inspection End Date: July 17, 2003

FEI: 3003108416

Location: NASHVILLE, TENNESSEE, United States of America

Investigators: Eric W Anderson

University of Iowa Pharmaceuticals [Iowa City / United States of America]

Inspection End Date: July 17, 2003

FEI: 1918751

Location: IOWA CITY, IOWA, United States of America

Investigators: John A Iwen, Erika V Butler

MDS Pharma Services [Saint-Laurent / Canada]

Inspection End Date: July 17, 2003

FEI: 3002809368

Location: SAINT-LAURENT, QUÉBEC, Canada

Investigators: Lisa P Oakes, Carol S Sanchez, Allen F Hall, Dr. Sriram Subramaniam, PhD, Martin K Yau, PhD, Nilufer M Tampal, PhD

Polarome International [Jersey City / United States of America]

Inspection End Date: July 17, 2003

FEI: 2418731

Location: JERSEY CITY, NEW JERSEY, United States of America

Investigators: Annemarie B Randow, Annemarie Bodnar

Ricca Chemical Company LLC [Arlington / United States of America]

Inspection End Date: July 17, 2003

FEI: 1625587

Location: ARLINGTON, TEXAS, United States of America

Investigators: Ronda Rloyd Jones, Pauline N Logan

BioMedical Life Systems, Inc. [Carlsbad / United States of America]

Inspection End Date: July 17, 2003

FEI: 2024292

Location: CARLSBAD, CALIFORNIA, United States of America

Investigators: Yvette E Guillermo

RPK Pharmaceuticals, Inc. [Union City / United States of America]

Inspection End Date: July 16, 2003

FEI: 2937511

Location: UNION CITY, CALIFORNIA, United States of America

Investigators: Carl Lee

JML Holdings, Inc. [Holland / United States of America]

Inspection End Date: July 16, 2003

FEI: 1519961

Location: HOLLAND, OHIO, United States of America

Investigators: Matthew B Casale

Medge Platforms, Inc. [New York / United States of America]

Inspection End Date: July 16, 2003

FEI: 3003381802

Location: NEW YORK, NEW YORK, United States of America

Investigators: Jacqueline S Warner

Gange, Steven N., M.D. [Salt Lake City / United States of America]

Inspection End Date: July 16, 2003

FEI: 3004029904

Location: SALT LAKE CITY, UTAH, United States of America

Investigators: Blake R Jensen

Alpha Therapeutic Corp [Fresno / United States of America]

Inspection End Date: July 16, 2003

FEI: 2970044

Location: FRESNO, CALIFORNIA, United States of America

Investigators: Helen J Hamaoka, Herbert E Arden

Helms Candy Co., Inc. [Bristol / United States of America]

Inspection End Date: July 16, 2003

FEI: 1110565

Location: BRISTOL, VIRGINIA, United States of America

Investigators: Bryan J Love

DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta [Rochester / United States of America]

Inspection End Date: July 15, 2003

FEI: 1315756

Location: ROCHESTER, NEW YORK, United States of America

Investigators: William C Lubas

Hoffmann La Roche Inc [Nutley / United States of America]

Inspection End Date: July 15, 2003

FEI: 2210844

Location: NUTLEY, NEW JERSEY, United States of America

Investigators: Wayne J Meyer, Regina T Brown

Ortho Technology, Inc. [Tampa / United States of America]

Inspection End Date: July 14, 2003

FEI: 1000132261

Location: TAMPA, FLORIDA, United States of America

Investigators: Bill Tacket, Jr

BioVectra Inc [Charlottetown / Canada]

Inspection End Date: July 14, 2003

FEI: 3004063541

Location: CHARLOTTETOWN, PRINCE EDWARD ISLAND, Canada

Investigators: George J Flynn, Katherine Szestypalow

Coating Place Inc [Verona / United States of America]

Inspection End Date: July 14, 2003

FEI: 2126906

Location: VERONA, WISCONSIN, United States of America

Investigators: Ronald R Ruff

President Global Corp. [Buena Park / United States of America]

Inspection End Date: July 14, 2003

FEI: 1000125412

Location: BUENA PARK, CALIFORNIA, United States of America

Investigators: Thao X Tran, Thao T Kwan

Hunt Brothers Products [Zanesville / United States of America]

Inspection End Date: July 14, 2003

FEI: 1522196

Location: ZANESVILLE, OHIO, United States of America

Investigators: Michael K Larson, Hugh M Mcclure, II

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. [Whitestown / United States of America]

Inspection End Date: July 11, 2003

FEI: 3002698769

Location: WHITESTOWN, INDIANA, United States of America

Investigators: Alberto Gutierrez, PhD, Charles M Spyr

Cogentix Medical LLC [Westborough / United States of America]

Inspection End Date: July 11, 2003

FEI: 1000136543

Location: WESTBOROUGH, MASSACHUSETTS, United States of America

Investigators: George T Allen, Jr, Andre S Lamontagne

NPBI International BV [Emmer-Compascuum / Netherlands]

Inspection End Date: July 11, 2003

FEI: 9610969

Location: EMMER-COMPASCUUM, DRENTHE, Netherlands

Investigators: Dr. Barbara D Paul, PhD, Douglas C Kovacs

Fareva Amboise [Pocé-Sur-Cisse / France]

Inspection End Date: July 11, 2003

FEI: 3000234005

Location: POCÉ-SUR-CISSE, CENTRE-VAL DE LOIRE, France

Investigators: Rebecca Rodriguez

Apotex Corp. [Lincolnshire / United States of America]

Inspection End Date: July 11, 2003

FEI: 3001576563

Location: LINCOLNSHIRE, ILLINOIS, United States of America

Investigators: Bruce H Mccullough

Aventis Bio-Services Inc [Lynchburg / United States of America]

Inspection End Date: July 11, 2003

FEI: 1000305540

Location: LYNCHBURG, VIRGINIA, United States of America

Investigators: Bryan J Love

Aphena Pharma Solutions [Whippany / United States of America]

Inspection End Date: July 10, 2003

FEI: 2245373

Location: WHIPPANY, NEW JERSEY, United States of America

Investigators: Keith M Reilly

Enzon Pharmaceuticals, Inc [South Plainfield / United States of America]

Inspection End Date: July 10, 2003

FEI: 2245253

Location: SOUTH PLAINFIELD, NEW JERSEY, United States of America

Investigators: Joy Rkozlowski Klena

Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics [Clifton / United States of America]

Inspection End Date: July 10, 2003

FEI: 2222033

Location: CLIFTON, NEW JERSEY, United States of America

Investigators: Tara R Gooen, Tara G Bizjak

San Up S.A. [Villa Yapeyú / Argentina]

Inspection End Date: July 10, 2003

FEI: 3003187221

Location: VILLA YAPEYÚ, BUENOS AIRES, Argentina

Investigators: Charles L Larson

E-BEAM Services, Inc. [Cranbury / United States of America]

Inspection End Date: July 10, 2003

FEI: 2245437

Location: CRANBURY, NEW JERSEY, United States of America

Investigators: Russell J Glapion

Biotrac Inc. [Miami / United States of America]

Inspection End Date: July 10, 2003

FEI: 3003619802

Location: MIAMI, FLORIDA, United States of America

Investigators: German Rivera

Power Medical Interventions, Inc [Langhorne / United States of America]

Inspection End Date: July 10, 2003

FEI: 3003456418

Location: LANGHORNE, PENNSYLVANIA, United States of America

Investigators: Michael J Nerz

Christian Aumais, M.D. [Mont-Royal / Canada]

Inspection End Date: July 10, 2003

FEI: 3003845197

Location: MONT-ROYAL, QUÉBEC, Canada

Investigators: Lisa P Oakes, Nancy A Bellamy, Nilufer M Tampal, PhD

AstraZeneca LP [Westborough / United States of America]

Inspection End Date: July 10, 2003

FEI: 1220331

Location: WESTBOROUGH, MASSACHUSETTS, United States of America

Investigators: Daryl A Dewoskin, George M Ibrahim, Kristina J Donohue, Philip F Istafanos, DMV, MS, Felix Maldonado, Amber G Wardwell

Perrigo New York, Inc. [Bronx / United States of America]

Inspection End Date: July 10, 2003

FEI: 2450054

Location: BRONX, NEW YORK, United States of America

Investigators: Ann M Stewart, Matthew A Spataro, Samuel T Walker

Omron Healthcare, Inc. [Lake Forest / United States of America]

Inspection End Date: July 10, 2003

FEI: 1450057

Location: LAKE FOREST, ILLINOIS, United States of America

Investigators: Karen Emasley Joseph, Lisa Hayka

BPR Health International [Moraga / United States of America]

Inspection End Date: July 9, 2003

FEI: 3000215185

Location: MORAGA, CALIFORNIA, United States of America

Investigators: CDR Rochelle B Young, RPh, MSA

LifeServe Blood Center [Sioux City / United States of America]

Inspection End Date: July 9, 2003

FEI: 1970344

Location: SIOUX CITY, IOWA, United States of America

Investigators: David L Miser

Westone Laboratories, Inc. [Renton / United States of America]

Inspection End Date: July 9, 2003

FEI: 3000215186

Location: RENTON, WASHINGTON, United States of America

Investigators: Dennis G Kawabata, Deborah A Nebenzahl

Suncare Medical, Inc. [Clearwater / United States of America]

Inspection End Date: July 9, 2003

FEI: 3003329159

Location: CLEARWATER, FLORIDA, United States of America

Investigators: Paul L Figarole, Jr, Keith A Schwartz

Oraceutical LLC [Lee / United States of America]

Inspection End Date: July 8, 2003

FEI: 3002983305

Location: LEE, MASSACHUSETTS, United States of America

Investigators: LCDR Debra Emerson, Megan A Haggerty

Sterigenics US LLC [Atlanta / United States of America]

Inspection End Date: July 8, 2003

FEI: 1018470

Location: ATLANTA, GEORGIA, United States of America

Investigators: Chateryl K Washington, Christie B Rice

William Lanzer, M.D. [Seattle / United States of America]

Inspection End Date: July 8, 2003

FEI: 3003569558

Location: SEATTLE, WASHINGTON, United States of America

Investigators: Terri L Dodds

UMC Inc [Monticello / United States of America]

Inspection End Date: July 8, 2003

FEI: 1000116127

Location: MONTICELLO, MINNESOTA, United States of America

Investigators: Billi Jom Johnson

Noven Pharmaceuticals, Inc. [Miami / United States of America]

Inspection End Date: July 7, 2003

FEI: 1000222037

Location: MIAMI, FLORIDA, United States of America

Investigators: Roy R Rinc, Jennifer M Menendez

Nutrius LLC [Kingsburg / United States of America]

Inspection End Date: July 7, 2003

FEI: 2914125

Location: KINGSBURG, CALIFORNIA, United States of America

Investigators: Ingrid A Zambrana

Watson Laboratories Caribe, Inc. [Río Abajo / Puerto Rico]

Inspection End Date: July 7, 2003

FEI: 1000208818

Location: RÍO ABAJO, PUERTO RICO, Puerto Rico

Investigators: Jose A Lopez, Lisa M Lopez, Juan Rjimenez Garcia

Bayer Healthcare, LLC [Milpitas / United States of America]

Inspection End Date: July 7, 2003

FEI: 1000221357

Location: MILPITAS, CALIFORNIA, United States of America

Investigators: Mark E Chan

Adenna Inc [Ontario / United States of America]

Inspection End Date: July 7, 2003

FEI: 3000719089

Location: ONTARIO, CALIFORNIA, United States of America

Investigators: William S Vitale, Aaron J Adler

Policlinico San Matteo IRCCS [Pavia / Italy]

Inspection End Date: July 3, 2003

FEI: 471603

Location: PAVIA, LOMBARDIA, Italy

Amneal Pharmaceuticals of New York, LLC [Hauppauge / United States of America]

Inspection End Date: July 3, 2003

FEI: 2434153

Location: HAUPPAUGE, NEW YORK, United States of America

Investigators: Dr. Robert C Horan, MD, Robert C Howard

University of the Sciences in Philadelphia IRB [Philadelphia / United States of America]

Inspection End Date: July 3, 2003

FEI: 2522158

Location: PHILADELPHIA, PENNSYLVANIA, United States of America

Investigators: Gayle S Lawson

SGS North America Inc. [Fairfield / United States of America]

Inspection End Date: July 3, 2003

FEI: 2214690

Location: FAIRFIELD, NEW JERSEY, United States of America

Investigators: Deborah B Nixon

St. Amour, Inc. [Stanton / United States of America]

Inspection End Date: July 3, 2003

FEI: 3003157197

Location: STANTON, CALIFORNIA, United States of America

Investigators: Ellen Stewart, Ellen N Stewart

Windstone Medical Incorporated [Billings / United States of America]

Inspection End Date: July 3, 2003

FEI: 3025168

Location: BILLINGS, MONTANA, United States of America

Investigators: Catherine J Laufmann

MEDIX [Ciudad Del Libertador General San Martín / Argentina]

Inspection End Date: July 3, 2003

FEI: 8043823

Location: CIUDAD DEL LIBERTADOR GENERAL SAN MARTÍN, PROVINCIA DE BUENOS AIRES, Argentina

Investigators: Charles L Larson

Dr. Valda Sevele/Ainars Judeiks (Center #2) [Riga / Latvia]

Inspection End Date: July 3, 2003

FEI: 3003996198

Location: RIGA, RIGA, Latvia

Investigators: Alicia M Mozzachio, Ni Aye Khin, MD, Melissa J Garcia

Boston Scientific Corporation [Murrieta / United States of America]

Inspection End Date: July 3, 2003

FEI: 2030666

Location: MURRIETA, CALIFORNIA, United States of America

Investigators: Yvette E Guillermo

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