Recently Published FDA Form 483s

Amgen Manufacturing Limited LLC [Ceiba Norte / Puerto Rico]

Inspection End Date: March 28, 2003

FEI: 1000110364

Location: CEIBA NORTE, PUERTO RICO, Puerto Rico

Investigators: Paula A Trost, Myriam M Sosa

EMD Millipore Corporation [Billerica / United States of America]

Inspection End Date: March 27, 2003

FEI: 2244894

Location: BILLERICA, MASSACHUSETTS, United States of America

Investigators: Karen F Tomaziefski

Biopure Corporation [Cambridge / United States of America]

Inspection End Date: March 27, 2003

FEI: 12222147

Location: CAMBRIDGE, MASSACHUSETTS, United States of America

Investigators: Yiping Jia, Susan Yu, Laurie P Norwood, Abdu Alayash, Megan A Haggerty

Roche Diagnostics Operations, Inc. [Indianapolis / United States of America]

Inspection End Date: March 27, 2003

FEI: 1823260

Location: INDIANAPOLIS, INDIANA, United States of America

Investigators: Charles M Spyr, Benjamin J Smith

The P.F. Laboratories Inc. [Totowa / United States of America]

Inspection End Date: March 27, 2003

FEI: 2242613

Location: TOTOWA, NEW JERSEY, United States of America

Investigators: Paul L Bellamy, Karen E D'orazio

Fujian Fukang Pharmaceutical Co. Ltd. [Taijiang / China]

Inspection End Date: March 27, 2003

FEI: 3003866335

Location: TAIJIANG, FUJIAN, China

Investigators: George J Flynn, Dennis Cantellops Paite

Julio J. Hajdenberg, MD [New Port Richey / United States of America]

Inspection End Date: March 26, 2003

FEI: 3003891571

Location: NEW PORT RICHEY, FLORIDA, United States of America

Investigators: Gerardo Z Vazquez

Charles F. Lovell, MD [Norfolk / United States of America]

Inspection End Date: March 26, 2003

FEI: 3003936455

Location: NORFOLK, VIRGINIA, United States of America

Investigators: LT Melanie M Mayor, USPHS

Sogo Pharmaceutical Co., Ltd. [Nakama / Japan]

Inspection End Date: March 26, 2003

FEI: 3002808220

Location: NAKAMA, FUKUOKA, Japan

Investigators: Jose A Lopez, Ted L Anderson

B. Braun Medical Inc. [Irvine / United States of America]

Inspection End Date: March 26, 2003

FEI: 2021236

Location: IRVINE, CALIFORNIA, United States of America

Investigators: Kim Lthomas Cruse, Donna Mwilliams Hill, PhD, Tracey T Duong, Jennifer M Gogley, Caryn M Mcnab

Invacare Corporation [Elyria / United States of America]

Inspection End Date: March 25, 2003

FEI: 1525712

Location: ELYRIA, OHIO, United States of America

Investigators: Benjamin J Dastoli

MEDLINE INDUSTRIES, LP - Northfield [Northfield / United States of America]

Inspection End Date: March 25, 2003

FEI: 1417592

Location: NORTHFIELD, ILLINOIS, United States of America

Investigators: Jesse A Vazquez

Barry S George MD [Columbus / United States of America]

Inspection End Date: March 24, 2003

FEI: 3003222603

Location: COLUMBUS, OHIO, United States of America

Investigators: Hugh M Mcclure, II

Baxter Healthcare Corporation [Round Lake / United States of America]

Inspection End Date: March 24, 2003

FEI: 1416980

Location: ROUND LAKE, ILLINOIS, United States of America

Investigators: Eric S Pittman, Patricia A Mcilroy, Chad E Schmear, Darrell E Luedtke, Mark E Frank

LUPIN LIMITED [Mandideep / India]

Inspection End Date: March 24, 2003

FEI: 3002807511

Location: MANDIDEEP, MADHYA PRADESH, India

Investigators: Dr. Robert C Horan, MD, Parul M Patel

Baxter Healthcare Corporation [Round Lake / United States of America]

Inspection End Date: March 24, 2003

FEI: 1416980

Location: ROUND LAKE, ILLINOIS, United States of America

Investigators: Eric S Pittman, Patricia A Mcilroy, Chad E Schmear, Darrell E Luedtke, Mark E Frank

Nicholas Pharmacy [Summersville / United States of America]

Inspection End Date: March 21, 2003

FEI: 3003807546

Location: SUMMERSVILLE, WEST VIRGINIA, United States of America

Investigators: James W Leonette

DUX Dental Inc. [Oxnard / United States of America]

Inspection End Date: March 20, 2003

FEI: 2017039

Location: OXNARD, CALIFORNIA, United States of America

Investigators: Katherine E Jacobitz

Arkhipov, Alexander V. M.D. [Arkhangelsk / Russian Federation]

Inspection End Date: March 20, 2003

FEI: 3003878134

Location: ARKHANGELSK, ARKHANGELSK OBLAST, Russian Federation

Investigators: Shari J Hromyak, Shari H Shambaugh

Celerion, Inc [Lincoln / United States of America]

Inspection End Date: March 20, 2003

FEI: 1915582

Location: LINCOLN, NEBRASKA, United States of America

Investigators: Patrick L Wisor, Linda R Kuchenthal

Laser, Inc [Tomball / United States of America]

Inspection End Date: March 20, 2003

FEI: 1640202

Location: TOMBALL, TEXAS, United States of America

Investigators: Hung V Le

Warner Graham LLLP [Cockeysville / United States of America]

Inspection End Date: March 19, 2003

FEI: 1110202

Location: COCKEYSVILLE, MARYLAND, United States of America

Investigators: Walter L Fava

Home Health Pavilion [Newburgh / United States of America]

Inspection End Date: March 19, 2003

FEI: 3000215279

Location: NEWBURGH, NEW YORK, United States of America

Investigators: Richard K Glabach

Peregrina Cheese Corp. [Brooklyn / United States of America]

Inspection End Date: March 19, 2003

FEI: 3002119179

Location: BROOKLYN, NEW YORK, United States of America

Investigators: Peter M Trunk, Mercedes G Castillo, Winston R Alejo

Anacapa Technologies, Inc [San Dimas / United States of America]

Inspection End Date: March 19, 2003

FEI: 3003693789

Location: SAN DIMAS, CALIFORNIA, United States of America

Investigators: Nancy E Byerly, Nancy E Smith

Baxter BioScience [Wien / Austria]

Inspection End Date: March 19, 2003

FEI: 300266912

Location: WIEN, WIEN, Austria

Investigators: Sidney B Priesmeyer, Stephen D Brown

Plopper, Michael G, MD [San Diego / United States of America]

Inspection End Date: March 18, 2003

FEI: 3003912394

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Mary Ewilkerson Brinsko

Smithfield BioScience, Inc. [Cincinnati / United States of America]

Inspection End Date: March 18, 2003

FEI: 1527761

Location: CINCINNATI, OHIO, United States of America

Investigators: Michael P Sheehan

Wasnich, Richard M.D. [Honolulu / United States of America]

Inspection End Date: March 17, 2003

FEI: 3003850604

Location: HONOLULU, HAWAII, United States of America

Investigators: Jennifer A Hickey

Fluid Energy Processing and Equipment Company [Hatfield / United States of America]

Inspection End Date: March 17, 2003

FEI: 1000071051

Location: HATFIELD, PENNSYLVANIA, United States of America

Investigators: Audrey Thereset Uy

ICON Development Solutions, LLC [Whitesboro / United States of America]

Inspection End Date: March 14, 2003

FEI: 1319349

Location: WHITESBORO, NEW YORK, United States of America

Investigators: David M Mcnew, Michael F Skelly, PhD

Able Laboratories Inc. [South Plainfield / United States of America]

Inspection End Date: March 14, 2003

FEI: 2245394

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

Investigators: Kristy A Zielny, Tara R Gooen, Tara G Bizjak

Preferred Meal Systems Inc [Los Angeles / United States of America]

Inspection End Date: March 14, 2003

FEI: 2024721

Location: LOS ANGELES, CALIFORNIA, United States of America

Investigators: Carol B Czerniak

OneBlood, Inc. [Palm Beach Gardens / United States of America]

Inspection End Date: March 14, 2003

FEI: 1070214

Location: PALM BEACH GARDENS, FLORIDA, United States of America

Investigators: Ana Delp Cintron, Courtney A Hunt, Courtney A Gilbert, Susan M Corrales, Susan M Turcovski, Ana P Barido

Teva Puerto Rico LLC [Fajardo / Puerto Rico]

Inspection End Date: March 14, 2003

FEI: 2619635

Location: FAJARDO, PUERTO RICO, Puerto Rico

Investigators: CDR Ileana Barreto Pettit, Ramon A Hernandez

Streck, Inc. [La Vista / United States of America]

Inspection End Date: March 14, 2003

FEI: 1950302

Location: LA VISTA, NEBRASKA, United States of America

Investigators: James D Planchon

Frank J. Criado, MD [Baltimore / United States of America]

Inspection End Date: March 14, 2003

FEI: 3003934346

Location: BALTIMORE, MARYLAND, United States of America

Investigators: Stephanie L Shapley, Joseph W Matthews

MBI Distributing, Inc [Benicia / United States of America]

Inspection End Date: March 14, 2003

FEI: 2939679

Location: BENICIA, CALIFORNIA, United States of America

Investigators: Raymond T Oji

Purdue Pharmaceuticals L.P. [Wilson / United States of America]

Inspection End Date: March 13, 2003

FEI: 3002960808

Location: WILSON, NORTH CAROLINA, United States of America

Investigators: Devaughn Edwards

Electronic Data Systems (eds) [Falls Church / United States of America]

Inspection End Date: March 13, 2003

FEI: 3000992933

Location: FALLS CHURCH, VIRGINIA, United States of America

Investigators: Gerald D Bromley, Jr, Ronald T Nowalk

Defense Health Clinical Systems [Falls Church / United States of America]

Inspection End Date: March 13, 2003

FEI: 1119523

Location: FALLS CHURCH, VIRGINIA, United States of America

Investigators: Gerald D Bromley, Jr, Ronald T Nowalk

Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company [Tierras Nuevas Saliente / Puerto Rico]

Inspection End Date: March 13, 2003

FEI: 2650089

Location: TIERRAS NUEVAS SALIENTE, PUERTO RICO, Puerto Rico

Investigators: Rebeca M Melendez, Jorge L Guadalupe

SRI International [Menlo Park / United States of America]

Inspection End Date: March 12, 2003

FEI: 2916579

Location: MENLO PARK, CALIFORNIA, United States of America

Investigators: CDR Rochelle B Young, RPh, MSA, Joseph P Iser, MD, Lance Mde Souza, MBA

NuBotanic Inc. [Gardena / United States of America]

Inspection End Date: March 12, 2003

FEI: 3000229687

Location: GARDENA, CALIFORNIA, United States of America

Investigators: Gabriel M Guevarra, Deborah Deborah, Deborah A Greco

Utah Medical Products, Inc [Midvale / United States of America]

Inspection End Date: March 12, 2003

FEI: 1718873

Location: MIDVALE, UTAH, United States of America

Investigators: Larry Gehring, Karen A Coleman, Blake R Jensen, Ginger M Sykes, Ricki A Chase, Richard W Clark, Marion W Nadeau

Bristol-Myers Squibb Company [New Brunswick / United States of America]

Inspection End Date: March 12, 2003

FEI: 2211101

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

Investigators: Byungja E Marciante

Dihoma Chemical & Manufacturing Inc [Mullins / United States of America]

Inspection End Date: March 12, 2003

FEI: 1000511932

Location: MULLINS, SOUTH CAROLINA, United States of America

Investigators: Nancy E Ford, Nancy E Fontaine

Medco Instruments Inc [Hickory Hills / United States of America]

Inspection End Date: March 12, 2003

FEI: 1420510

Location: HICKORY HILLS, ILLINOIS, United States of America

Investigators: Jesse A Vazquez, Mark E Frank

Biological Research Solutions, Inc. [Rochester Hills / United States of America]

Inspection End Date: March 12, 2003

FEI: 3002907674

Location: ROCHESTER HILLS, MICHIGAN, United States of America

Investigators: Laureen F Kononen, Azza Talaat

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

Inspection End Date: March 12, 2003

FEI: 2210277

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

Investigators: Emest F Bizjak, Daniel J Grabicki

Bridgeport Wholesale Products, Inc [Lakewood / United States of America]

Inspection End Date: March 11, 2003

FEI: 3021063

Location: LAKEWOOD, WASHINGTON, United States of America

Investigators: Lisa K Capron, Robert D Tollefsen

Cleveland Clinic [Cleveland / United States of America]

Inspection End Date: March 11, 2003

FEI: 1573778

Location: CLEVELAND, OHIO, United States of America

Investigators: Nancy L Neiger

Stanley F. Malamed, DDS [Los Angeles / United States of America]

Inspection End Date: March 11, 2003

Location: LOS ANGELES, CALIFORNIA, United States of America

Investigators: Ronald L Koller

Exelead, Inc. [Indianapolis / United States of America]

Inspection End Date: March 10, 2003

FEI: 1000517970

Location: INDIANAPOLIS, INDIANA, United States of America

Investigators: Jeffrey A Sommers

SMK Imaging LLC [Elmsford / United States of America]

Inspection End Date: March 10, 2003

FEI: 2431643

Location: ELMSFORD, NEW YORK, United States of America

Investigators: Jacqueline S Warner

Biogen Idec Inc [San Diego / United States of America]

Inspection End Date: March 7, 2003

FEI: 3001238023

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Mariza M Jafary

Aseptico Inc [Woodinville / United States of America]

Inspection End Date: March 7, 2003

FEI: 3017604

Location: WOODINVILLE, WASHINGTON, United States of America

Investigators: Astrida B Mattson

Old Dominion Eye Foundation, Inc. [North Chesterfield / United States of America]

Inspection End Date: March 7, 2003

FEI: 3001236469

Location: NORTH CHESTERFIELD, VIRGINIA, United States of America

Investigators: Gerald Mierle, Karen S Anthony

Ivax Pharmaceuticals Inc [Northvale / United States of America]

Inspection End Date: March 7, 2003

FEI: 2219541

Location: NORTHVALE, NEW JERSEY, United States of America

Investigators: Keith M Reilly, Douglas C Kovacs

Dr Reddy's Laboratories Limited [Hyderabad / India]

Inspection End Date: March 6, 2003

FEI: 3005448030

Location: HYDERABAD, TELANGANA, India

Investigators: Edwin Melendez

Alan F. Barker, MD [Portland / United States of America]

Inspection End Date: March 6, 2003

FEI: 3003947058

Location: PORTLAND, OREGON, United States of America

Investigators: Jane M Kreis

Colgate Palmolive Company [Salford / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: March 6, 2003

FEI: 3003973559

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

Investigators: Regina T Brown, Shirley H Isbill

Athea Laboratories Inc [Milwaukee / United States of America]

Inspection End Date: March 5, 2003

FEI: 1000221013

Location: MILWAUKEE, WISCONSIN, United States of America

Investigators: Jesse P Romenesko, Jeffry A Bernhardt

Image Analysis Inc [Columbia / United States of America]

Inspection End Date: March 5, 2003

FEI: 2027364

Location: COLUMBIA, KENTUCKY, United States of America

Investigators: Karen M Bryerton, Karen M Cooper, Mark E Parmon

Vision Chips Inc [Laguna Niguel / United States of America]

Inspection End Date: March 5, 2003

FEI: 3001237826

Location: LAGUNA NIGUEL, CALIFORNIA, United States of America

Investigators: Mei Chen Mu

Cardinal Medical Specialties Inc [Louisville / United States of America]

Inspection End Date: March 5, 2003

FEI: 3002864976

Location: LOUISVILLE, KENTUCKY, United States of America

Investigators: Lauren R Collins, Lauren R Coffey, Maribeth G Niesen, Maribeth G Grattan

Strategic Veterinary Pharmaceuticals, Inc. [Wathena / United States of America]

Inspection End Date: March 4, 2003

FEI: 1923979

Location: WATHENA, KANSAS, United States of America

Investigators: Michele Perry Williams

DairiConcepts, L.P. [El Dorado Springs / United States of America]

Inspection End Date: March 3, 2003

FEI: 1921123

Location: EL DORADO SPRINGS, MISSOURI, United States of America

Investigators: Julie N Vosilus, Ted L Anderson

ENDO USA, Inc. [Rochester / United States of America]

Inspection End Date: March 3, 2003

FEI: 1818977

Location: ROCHESTER, MICHIGAN, United States of America

Investigators: Patsy J Domingo, Art O Czabaniuk