Recently Published FDA Form 483s

Schering-Plough Products LLC [Coto Norte / Puerto Rico]

Inspection End Date: June 13, 2001

FEI: 2650149

Location: COTO NORTE, PUERTO RICO, Puerto Rico

Investigators: Ivis L Negron, Jose F Pedro, CDR Ileana Barreto Pettit, Dr. Carmelo Rosa

MDS Pharma Services [Bothell / United States of America]

Inspection End Date: June 13, 2001

FEI: 1000146743

Location: BOTHELL, WASHINGTON, United States of America

Investigators: Astrida B Mattson, Paula A Trost

Bass & Boney, Inc. [Chapel Hill / United States of America]

Inspection End Date: June 13, 2001

FEI: 3001451338

Location: CHAPEL HILL, NORTH CAROLINA, United States of America

Investigators: Amy H Ruble

Abbott Chemical Plant, Inc. [Florida Afuera / Puerto Rico]

Inspection End Date: June 12, 2001

FEI: 2650257

Location: FLORIDA AFUERA, PUERTO RICO, Puerto Rico

Investigators: Jose A Lopez, Jorge L Guadalupe

Howard Young Medical Cntr, Inc. [Woodruff / United States of America]

Inspection End Date: June 12, 2001

FEI: 2171892

Location: WOODRUFF, WISCONSIN, United States of America

Investigators: Dale A Nyberg

MML Diagnostics Packaging, Inc [Troutdale / United States of America]

Inspection End Date: June 12, 2001

FEI: 3018348

Location: TROUTDALE, OREGON, United States of America

Investigators: Gary L Zaharek

Univar Solutions USA Inc [Norcross / United States of America]

Inspection End Date: June 11, 2001

FEI: 1051658

Location: NORCROSS, GEORGIA, United States of America

Investigators: Leslie W Gilbert, Leslie W Jones

Bachem Americas, Inc. [Torrance / United States of America]

Inspection End Date: June 8, 2001

FEI: 2024023

Location: TORRANCE, CALIFORNIA, United States of America

Investigators: Julie A Stocklin, Caryn M Everly, Caryn M Mcnab, Julie A Rorberg

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

Inspection End Date: June 8, 2001

FEI: 1718873

Location: MIDVALE, UTAH, United States of America

Investigators: Thai T Duong

Labcorp Bedford LLC. [Bedford / United States of America]

Inspection End Date: June 8, 2001

FEI: 1220528

Location: BEDFORD, MASSACHUSETTS, United States of America

Investigators: Gary J Hagan

Lonza Biologics, Inc. [Portsmouth / United States of America]

Inspection End Date: June 8, 2001

FEI: 3001451441

Location: PORTSMOUTH, NEW HAMPSHIRE, United States of America

Investigators: Lori A Holmquist, M Pedgen, L Norwood

Amgen, Inc [Newbury Park / United States of America]

Inspection End Date: June 8, 2001

FEI: 2026154

Location: NEWBURY PARK, CALIFORNIA, United States of America

Investigators: Terri L Dodds, Jennifer Gogley, Jennifer M Gogley, Amalia C Himaya

CAIRE INC [San Diego / United States of America]

Inspection End Date: June 8, 2001

FEI: 1000519984

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Scott K Zika

Sitek Research Laboratories [Rockville / United States of America]

Inspection End Date: June 7, 2001

FEI: 1121584

Location: ROCKVILLE, MARYLAND, United States of America

Investigators: Lynette P Salisbury, Barbara A Gullick

York Pharmaceuticals Inc [Kansas City / United States of America]

Inspection End Date: June 7, 2001

FEI: 3001451284

Location: KANSAS CITY, KANSAS, United States of America

Investigators: Dana D Carter, SR DDS, Gwyn G Dickinson

Catalent Pharma Solutions, LLC [Winchester / United States of America]

Inspection End Date: June 7, 2001

FEI: 1000122400

Location: WINCHESTER, KENTUCKY, United States of America

Investigators: Kathleen D Culver, Mark E Parmon

W L Gore & Associates, Inc. [Flagstaff / United States of America]

Inspection End Date: June 7, 2001

FEI: 2017233

Location: FLAGSTAFF, ARIZONA, United States of America

Investigators: Cathy L Condon, Paul R Whitby

Gilster Mary Lee Corp [Joplin / United States of America]

Inspection End Date: June 6, 2001

FEI: 1000158467

Location: JOPLIN, MISSOURI, United States of America

Investigators: Kristi M Hampton Thurston

Sterigenics US LLC [Lewis Center / United States of America]

Inspection End Date: June 6, 2001

FEI: 1526534

Location: LEWIS CENTER, OHIO, United States of America

Investigators: Phillip M Pontikos

Cook Incorporated [Bloomington / United States of America]

Inspection End Date: June 6, 2001

FEI: 1820334

Location: BLOOMINGTON, INDIANA, United States of America

Investigators: Charles M Spyr

Najdek Produce Company Inc [Portland / United States of America]

Inspection End Date: June 5, 2001

FEI: 3081090

Location: PORTLAND, OREGON, United States of America

Investigators: Paul F Rader, Paul Rader

Texas Tech Univ Health Sciences Ctr-El Paso-MOBILE [El Paso / United States of America]

Inspection End Date: June 5, 2001

FEI: 1000517263

Location: EL PASO, TEXAS, United States of America

Investigators: Daniell Gill, Jr, Ve Garcia

Schering-Plough Products L.L.C. [Las Piedras / Puerto Rico]

Inspection End Date: June 5, 2001

FEI: 100176708

Location: LAS PIEDRAS, PUERTO RICO, Puerto Rico

Investigators: Arlene M Badillo, Steven B Barber

Amarin Pharmaceuticals Inc [Warren / United States of America]

Inspection End Date: June 4, 2001

FEI: 3003323526

Location: WARREN, NEW JERSEY, United States of America

Investigators: Byungja E Marciante

McNeil PPC Inc. [Parsippany / United States of America]

Inspection End Date: June 4, 2001

FEI: 2211583

Location: PARSIPPANY, NEW JERSEY, United States of America

Investigators: Keith M Reilly

Berd,David A Md [Philadelphia / United States of America]

Inspection End Date: June 1, 2001

FEI: 2521506

Location: PHILADELPHIA, PENNSYLVANIA, United States of America

Investigators: Robert B Shibuya, MD, Mike M Rashti

O'Neal Scientific Services Inc [Saint Louis / United States of America]

Inspection End Date: May 31, 2001

FEI: 1937225

Location: SAINT LOUIS, MISSOURI, United States of America

Investigators: Gloria J Champagne

Roxane Laboratories, Inc [Columbus / United States of America]

Inspection End Date: May 31, 2001

FEI: 1525799

Location: COLUMBUS, OHIO, United States of America

Investigators: Frederick M Lochner, Karen M Kondas

AIRGAS USA, LLC [Chattanooga / United States of America]

Inspection End Date: May 31, 2001

FEI: 1022618

Location: CHATTANOOGA, TENNESSEE, United States of America

Investigators: Pamela M Thomas, Linda A Gregory Duty

GRINDEKS JSC [Riga / Latvia]

Inspection End Date: May 31, 2001

FEI: 3001597955

Location: RIGA, RIGA, Latvia

Investigators: Vlada Matusovsky

DMX-Works Imaging, Inc. [Palm Harbor / United States of America]

Inspection End Date: May 31, 2001

FEI: 1000221974

Location: PALM HARBOR, FLORIDA, United States of America

Investigators: Ronald T Weber

Wisconsin Center for Clinical Research [Milwaukee / United States of America]

Inspection End Date: May 31, 2001

Location: MILWAUKEE, WISCONSIN, United States of America

Investigators: Constance L Richard

Datascope Corp. [Fairfield / United States of America]

Inspection End Date: May 30, 2001

FEI: 1000222374

Location: FAIRFIELD, NEW JERSEY, United States of America

Investigators: Kinh Q Mac

Remel, Inc [Lenexa / United States of America]

Inspection End Date: May 30, 2001

FEI: 1924669

Location: LENEXA, KANSAS, United States of America

Investigators: Nadine Nanko Johnson, Minerva Rogers

Linde Inc. [Kansas City / United States of America]

Inspection End Date: May 30, 2001

FEI: 1921174

Location: KANSAS CITY, MISSOURI, United States of America

Investigators: Norman Wong, Dina K West, James D Planchon

Custom Manufacturing Corporation [Medley / United States of America]

Inspection End Date: May 30, 2001

FEI: 3003086315

Location: MEDLEY, FLORIDA, United States of America

Investigators: Victor Spanioli, Victor Sanivli

Fisher Scientific Co., LLC [Bridgewater / United States of America]

Inspection End Date: May 25, 2001

FEI: 2242462

Location: BRIDGEWATER, NEW JERSEY, United States of America

Investigators: Kristy A Zielny, Kelli F Dobilas, Amy L Singer, Kelli F Regenye

CP Pharmaceuticals Ltd [Wrexham / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: May 25, 2001

FEI: 3003369660

Location: WREXHAM, WALES, United Kingdom of Great Britain and Northern Ireland

Investigators: Regina T Brown, Lydia I Rosas Marty

Fresenius Kabi USA, LLC [Grand Island / United States of America]

Inspection End Date: May 25, 2001

FEI: 3001833549

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

Investigators: Simone E Pitts, Parul M Patel, John A Podsadowski

Getinge Sourcing LLC [Rochester / United States of America]

Inspection End Date: May 25, 2001

FEI: 1314329

Location: ROCHESTER, NEW YORK, United States of America

Investigators: Kim M Downing

Avax Technologies [Philadelphia / United States of America]

Inspection End Date: May 25, 2001

FEI: 3003157217

Location: PHILADELPHIA, PENNSYLVANIA, United States of America

Investigators: Robert B Shibuya, MD, Mike M Rashti, Michele Keane Moore, PhD

Jiangsu Hengrui Medicine Co., Ltd. [Xinpu / China]

Inspection End Date: May 25, 2001

FEI: 3002807476

Location: XINPU, JIANGSU, China

Investigators: Nasir Ali, PhD, Syed N Ali, John D White

CSL Behring L.L.C. [Bradley / United States of America]

Inspection End Date: May 24, 2001

FEI: 1410248

Location: BRADLEY, ILLINOIS, United States of America

Investigators: David Perkins, Eliezar Ramos, Jeanne M Morris, Humera T Khan

SCHERER DRUG DELIVERY SYSTEMS [Swindon / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: May 24, 2001

FEI: 9614378

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

Investigators: Richard H Penta

NAMAR Foods [Paramount / United States of America]

Inspection End Date: May 24, 2001

FEI: 2015982

Location: PARAMOUNT, CALIFORNIA, United States of America

Investigators: Nianna C Burns, Phillip L Toy, Nianna M Capalia

Technical Products, Inc. [Buford / United States of America]

Inspection End Date: May 24, 2001

FEI: 1000511237

Location: BUFORD, GEORGIA, United States of America

Investigators: Karen A Coleman

Central California Blood Center [Fresno / United States of America]

Inspection End Date: May 24, 2001

FEI: 2970324

Location: FRESNO, CALIFORNIA, United States of America

Investigators: Herbert E Arden

GlaxoSmithKline [Montrose / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: May 24, 2001

FEI: 3002807080

Location: MONTROSE, SCOTLAND, United Kingdom of Great Britain and Northern Ireland

Investigators: Patsy J Domingo, Jean Salemme, PhD

P & L Development, LLC [Copiague / United States of America]

Inspection End Date: May 23, 2001

FEI: 2410283

Location: COPIAGUE, NEW YORK, United States of America

Investigators: Lawrence W Farina

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

Inspection End Date: May 23, 2001

FEI: 2214690

Location: FAIRFIELD, NEW JERSEY, United States of America

Investigators: Keith M Reilly, Douglas C Kovacs

Datwyler Pharma Packaging [Alken / Belgium]

Inspection End Date: May 23, 2001

FEI: 1000165860

Location: ALKEN, VLAANDEREN, Belgium

Investigators: Gerald B Seaborn, Jr, Nancy A Saxenian Emmons

Sharp Corporation [Allentown / United States of America]

Inspection End Date: May 23, 2001

FEI: 2210051

Location: ALLENTOWN, PENNSYLVANIA, United States of America

Investigators: Erin D Mccaffery

EUSA Pharma (USA) Inc. [Langhorne / United States of America]

Inspection End Date: May 23, 2001

FEI: 2246903

Location: LANGHORNE, PENNSYLVANIA, United States of America

Investigators: Jean M Kelahan

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

Inspection End Date: May 22, 2001

FEI: 3001238023

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Sidney B Priesmeyer, Prabhu P Raju

Brendel Kirkwood [Kinsley / United States of America]

Inspection End Date: May 22, 2001

FEI: 1929903

Location: KINSLEY, KANSAS, United States of America

Investigators: Cynthia Hotovy, Darrah

Abbott Laboratories [Columbus / United States of America]

Inspection End Date: May 21, 2001

FEI: 1000136098

Location: COLUMBUS, OHIO, United States of America

Investigators: Phillip M Pontikos

Hikma Pharmaceuticals USA Inc. [Cherry Hill / United States of America]

Inspection End Date: May 21, 2001

FEI: 2220525

Location: CHERRY HILL, NEW JERSEY, United States of America

Investigators: Marea K Harmon, Margaret M Sands, Russell J Glapion, Paul L Bellamy

New York Blood Center, Inc. [New York / United States of America]

Inspection End Date: May 21, 2001

FEI: 2473015

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

Investigators: Evelyn Taha, Laura Schankweiler, Laura M Howard, Gloria E Parra

Saputo Cheese USA Inc [South Gate / United States of America]

Inspection End Date: May 18, 2001

FEI: 2022119

Location: SOUTH GATE, CALIFORNIA, United States of America

Investigators: Phillip L Toy

Community Blood Center dba Community Tissue Services [Germantown / United States of America]

Inspection End Date: May 18, 2001

FEI: 1000307546

Location: GERMANTOWN, TENNESSEE, United States of America

Investigators: Brian S Lynch

KAKEN Pharmaceutical Co., LTD [Gensuke / Japan]

Inspection End Date: May 18, 2001

FEI: 3002807376

Location: GENSUKE, SHIZUOKA, Japan

Investigators: Dr. Robert C Horan, MD, Susan W Ting

CASA Lab, Inc. (d.b.a. Walking Bird International, Inc. [Silver Creek / United States of America]

Inspection End Date: May 18, 2001

FEI: 2320655

Location: SILVER CREEK, MISSISSIPPI, United States of America

Investigators: Marvin D Jones

Watson Laboratories, Inc. [Hialeah / United States of America]

Inspection End Date: May 18, 2001

FEI: 1034205

Location: HIALEAH, FLORIDA, United States of America

Investigators: Roy R Rinc, Jennifer M Menendez

Watson Laboratories, Inc. [Corona / United States of America]

Inspection End Date: May 18, 2001

FEI: 2024830

Location: CORONA, CALIFORNIA, United States of America

Investigators: Sue Lee Chan, Valerie L Whipp, Virgilio F Pacio, CSO

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

Inspection End Date: May 18, 2001

FEI: 1416980

Location: ROUND LAKE, ILLINOIS, United States of America

Investigators: Bruce H Mccullough

Edge Biologicals Inc [Memphis / United States of America]

Inspection End Date: May 18, 2001

FEI: 1049818

Location: MEMPHIS, TENNESSEE, United States of America

Investigators: Abraham M Maekele

Samin K. Sharma [New York / United States of America]

Inspection End Date: May 18, 2001

FEI: 3003354459

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

Investigators: L Gnnmassimia Massimilla, PharmD

Prizm Medical, Inc. [Duluth / United States of America]

Inspection End Date: May 18, 2001

FEI: 1055808

Location: DULUTH, GEORGIA, United States of America

Investigators: Chateryl K Washington, Paul W Moy

Professional Disposables International, Inc. [Orangeburg / United States of America]

Inspection End Date: May 17, 2001

FEI: 2411192

Location: ORANGEBURG, NEW YORK, United States of America

Investigators: Steven M Weinman, Jacqueline S Warner, Parul M Patel

Weber Laboratories Inc [Irvine / United States of America]

Inspection End Date: May 17, 2001

FEI: 2027367

Location: IRVINE, CALIFORNIA, United States of America

Investigators: M Jasnethoson Thompson, Mihaly S Ligmond, Jasmine N Thompson, Yumi J Hiramine

aap Implantate AG [Berlin / Germany]

Inspection End Date: May 17, 2001

FEI: 9612609

Location: BERLIN, BERLIN, Germany

Investigators: Kelvin Cheung

Curia New Mexico, LLC [Albuquerque / United States of America]

Inspection End Date: May 17, 2001

FEI: 1643045

Location: ALBUQUERQUE, NEW MEXICO, United States of America

Investigators: Patricia A Brown, Patricia A Cortez

Takeda Ireland Limited [Bray / Ireland]

Inspection End Date: May 17, 2001

FEI: 3002870748

Location: BRAY, WICKLOW, Ireland

Investigators: Patsy J Domingo

Bristol-Myers Squibb Manufacturing Company Unlimited Company [Río Abajo / Puerto Rico]

Inspection End Date: May 16, 2001

FEI: 2623458

Location: RÍO ABAJO, PUERTO RICO, Puerto Rico

Investigators: Sonia M Monges

MINO Corp, DBA Great Midwest Seafood Company [Davenport / United States of America]

Inspection End Date: May 16, 2001

FEI: 1000118249

Location: DAVENPORT, IOWA, United States of America

Investigators: Shanna R Haden, Shanna R Ausfahl

Dornier Medtech America, Inc. [Kennesaw / United States of America]

Inspection End Date: May 15, 2001

FEI: 1037955

Location: KENNESAW, GEORGIA, United States of America

Investigators: Stephanie E Hubbard

DFG Foods, L.L.C. [Chicago / United States of America]

Inspection End Date: May 15, 2001

FEI: 1484523

Location: CHICAGO, ILLINOIS, United States of America

Investigators: Thomas W Nojek

INyX USA, Ltd. [Aguada / Puerto Rico]

Inspection End Date: May 14, 2001

FEI: 2650125

Location: AGUADA, PUERTO RICO, Puerto Rico

Investigators: Carlos A Medina

Ramsdell, Joseph W Md [San Diego / United States of America]

Inspection End Date: May 14, 2001

FEI: 2082291

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Thomas R Beilke