Recently Published FDA Form 483s

Ash Stevens LLC [Riverview / United States of America]

Inspection End Date: December 21, 2000

FEI: 1824725

Location: RIVERVIEW, MICHIGAN, United States of America

Investigators: Patsy J Domingo, Cheryl M Monroe, Alanna L Mussawwir Bias

Frank M Ludwig MD [Virginia Beach / United States of America]

Inspection End Date: December 21, 2000

FEI: 3003193361

Location: VIRGINIA BEACH, VIRGINIA, United States of America

Investigators: LT Melanie M Mayor, USPHS

Stryker Ireland, Ltd., Instruments Division [Cork / Ireland]

Inspection End Date: December 21, 2000

FEI: 3003164255

Location: CORK, CORK, Ireland

Investigators: Jacqueline S Warner

Creative Medical Corp. [Certenejas / Puerto Rico]

Inspection End Date: December 21, 2000

FEI: 2611272

Location: CERTENEJAS, PUERTO RICO, Puerto Rico

Investigators: CDR Ileana Barreto Pettit

Isomedix Operations, Inc. [Sandy / United States of America]

Inspection End Date: December 21, 2000

FEI: 1720929

Location: SANDY, UTAH, United States of America

Investigators: Ricki A Chase

Mitchell, Robert E. MD [Virginia Beach / United States of America]

Inspection End Date: December 21, 2000

FEI: 3003193348

Location: VIRGINIA BEACH, VIRGINIA, United States of America

Investigators: LT Melanie M Mayor, USPHS

Accu-Glass [Saint Louis / United States of America]

Inspection End Date: December 20, 2000

FEI: 1925253

Location: SAINT LOUIS, MISSOURI, United States of America

Investigators: Philip J Boston

J Lloyd Medical Inc [West Berlin / United States of America]

Inspection End Date: December 20, 2000

FEI: 1000121767

Location: WEST BERLIN, NEW JERSEY, United States of America

Investigators: Loretta Nemchik, Karen F Tomaziefski

Gambro Dialysatoren GmbH & Co. KG [Hechingen / Germany]

Inspection End Date: December 20, 2000

FEI: 9611369

Location: HECHINGEN, BADEN-WÜRTTEMBERG, Germany

Investigators: Paul R Whitby

Phyne Pharmaceuticals [Bozeman / United States of America]

Inspection End Date: December 20, 2000

FEI: 3000203465

Location: BOZEMAN, MONTANA, United States of America

Investigators: Robert A Williams

Omicron Quimica, S.A. [Sant Vicenç De Montalt / Spain]

Inspection End Date: December 20, 2000

FEI: 3002883638

Location: SANT VICENÇ DE MONTALT, CATALUNYA, Spain

Investigators: Susanna E Ford, Rochelle K Kimmel

Altasciences Preclinical Seattle, LLC [Everett / United States of America]

Inspection End Date: December 19, 2000

FEI: 3003199588

Location: EVERETT, WASHINGTON, United States of America

Investigators: Linda S Leja

Laser Images Inc [Van Nuys / United States of America]

Inspection End Date: December 19, 2000

FEI: 2020723

Location: VAN NUYS, CALIFORNIA, United States of America

Investigators: Suzie L Kent

Reddy, Duttula M.D. [Springfield / United States of America]

Inspection End Date: December 19, 2000

FEI: 3003215558

Location: SPRINGFIELD, ILLINOIS, United States of America

Investigators: Susan D Yuscius

Gliatech Inc [Beachwood / United States of America]

Inspection End Date: December 19, 2000

FEI: 3001596592

Location: BEACHWOOD, OHIO, United States of America

Investigators: Frederick M Lochner, Laureen M Geniusz

Upsher-Smith Laboratories, LLC [Denver / United States of America]

Inspection End Date: December 19, 2000

FEI: 1719991

Location: DENVER, COLORADO, United States of America

Investigators: Patricia A Brown, Michael J Kuchta, Katherine Szestypalow, Patricia A Cortez

Howmedica Osteonics Corp [Allendale / United States of America]

Inspection End Date: December 19, 2000

FEI: 2243265

Location: ALLENDALE, NEW JERSEY, United States of America

Investigators: Robert G Ruff

Shelhigh, Inc. [Millburn / United States of America]

Inspection End Date: December 18, 2000

FEI: 2247123

Location: MILLBURN, NEW JERSEY, United States of America

Investigators: Kinh Q Mac, Frank J Marciniak

Amram Inc. [Rathdrum / United States of America]

Inspection End Date: December 18, 2000

FEI: 3002798258

Location: RATHDRUM, IDAHO, United States of America

Investigators: James C Henry, Dolores E Price

Apria Healthcare, Inc [Greeley / United States of America]

Inspection End Date: December 18, 2000

FEI: 1721864

Location: GREELEY, COLORADO, United States of America

Investigators: Theressa B Madison, Theressa B Smith

Merck, Sharp & Dohme (Australia) Pty. [Sydney / Australia]

Inspection End Date: December 15, 2000

FEI: 3002807581

Location: SYDNEY, NEW SOUTH WALES, Australia

Investigators: Robert D Tollefsen, Thomas J Arista

ALLERMED LABORATORY, INC. [San Diego / United States of America]

Inspection End Date: December 15, 2000

FEI: 2018803

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Randall N Johnson, Christina V Santos

W. R. Grace & Co.-Conn. [South Haven / United States of America]

Inspection End Date: December 15, 2000

FEI: 1826582

Location: SOUTH HAVEN, MICHIGAN, United States of America

Investigators: Leslie A Paul, Darren S Morgan

Reed-Lane, Inc. [Wayne / United States of America]

Inspection End Date: December 15, 2000

FEI: 3002772224

Location: WAYNE, NEW JERSEY, United States of America

Investigators: Douglas C Kovacs

Bristol-Myers Squibb Co., Inc. [East Syracuse / United States of America]

Inspection End Date: December 15, 2000

FEI: 1317461

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

Investigators: Lawrence W Farina, Michael Levin, John A Podsadowski

Dixie Chemical Company [Pasadena / United States of America]

Inspection End Date: December 15, 2000

FEI: 1649437

Location: PASADENA, TEXAS, United States of America

Investigators: Edward D Edmiston, Kari M Laynor

Allergan Sales, LLC [Waco / United States of America]

Inspection End Date: December 15, 2000

FEI: 1643525

Location: WACO, TEXAS, United States of America

Investigators: Jose Martinez, Jr, Andrea A Branche

Patheon Manufacturing Services LLC [Greenville / United States of America]

Inspection End Date: December 15, 2000

FEI: 1018495

Location: GREENVILLE, NORTH CAROLINA, United States of America

Investigators: Penny H Mccarver, Vicky C Stoakes, Devaughn Edwards

Fresenius Kabi USA, LLC [Melrose Park / United States of America]

Inspection End Date: December 14, 2000

FEI: 1450022

Location: MELROSE PARK, ILLINOIS, United States of America

Investigators: Alicia M Mozzachio, Jason F Chancey, Bruce H Mccullough

Alpha Therapeutic Corporation [Mcallen / United States of America]

Inspection End Date: December 14, 2000

FEI: 1626444

Location: MCALLEN, TEXAS, United States of America

Investigators: Maira P Brading, Trinidad D Barreras

Savage, Susan M.D. [Littleton / United States of America]

Inspection End Date: December 14, 2000

FEI: 3003181995

Location: LITTLETON, COLORADO, United States of America

Investigators: Kelly D Moore

Tekna Manufacturing, LLC [Zephyrhills / United States of America]

Inspection End Date: December 14, 2000

FEI: 3002919078

Location: ZEPHYRHILLS, FLORIDA, United States of America

Investigators: Vivian Garcia, Ve Garcia

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

Inspection End Date: December 14, 2000

FEI: 2650149

Location: COTO NORTE, PUERTO RICO, Puerto Rico

Investigators: Wanda J Torres, Steven B Barber

Moehs Catalana SL [Rubí / Spain]

Inspection End Date: December 14, 2000

FEI: 3002807632

Location: RUBÍ, CATALUNYA, Spain

Investigators: Susanna E Ford, Rochelle K Kimmel

Ulrich Gmbh & Co. KG [Ulm / Germany]

Inspection End Date: December 14, 2000

FEI: 3002807156

Location: ULM, BADEN-WÜRTTEMBERG, Germany

Investigators: Paul R Whitby

Medical Device Consulting [Centerville / United States of America]

Inspection End Date: December 14, 2000

FEI: 3003160325

Location: CENTERVILLE, MASSACHUSETTS, United States of America

Investigators: Sandra P White

DR. KARL DANTENDORFER [Wien / Austria]

Inspection End Date: December 14, 2000

Location: WIEN, WIEN, Austria

Investigators: Constance Lewin, MD, Gerald N Mcgirl, DDS

Myer, Edwin C MD [Richmond / United States of America]

Inspection End Date: December 13, 2000

FEI: 3003188283

Location: RICHMOND, VIRGINIA, United States of America

Investigators: Dianne H Milazzo, Gerald D Bromley, Jr, Dianne T Hamilton

Kindeva Drug Delivery L.P. [Northridge / United States of America]

Inspection End Date: December 13, 2000

FEI: 2010441

Location: NORTHRIDGE, CALIFORNIA, United States of America

Investigators: Terri L Dodds, Julie A Stocklin, Caryn M Everly, Caryn M Mcnab, Julie A Rorberg

Atlanta Center for Medical Research [Atlanta / United States of America]

Inspection End Date: December 13, 2000

FEI: 3006128709

Location: ATLANTA, GEORGIA, United States of America

Investigators: Stephanie E Hubbard, Myla D Chapman

Jonal Bakery Ltd [Chicago / United States of America]

Inspection End Date: December 12, 2000

FEI: 1416140

Location: CHICAGO, ILLINOIS, United States of America

Investigators: Rosemary Wood Sexton

Thermo-Pak Co [Wood Dale / United States of America]

Inspection End Date: December 12, 2000

FEI: 1450706

Location: WOOD DALE, ILLINOIS, United States of America

Investigators: Debra I Love, Lisa Hayka

Del Ray Labs, Inc. [Center Point / United States of America]

Inspection End Date: December 12, 2000

FEI: 109820

Location: CENTER POINT, ALABAMA, United States of America

Investigators: Kimberly L Mcmillan

Genesis Pharmaceutical, Inc. [Henderson / United States of America]

Inspection End Date: December 11, 2000

FEI: 1810239

Location: HENDERSON, NEVADA, United States of America

Investigators: Azza Talaat, Renee L Rice, PhD, Miah I Schneider

Elanco Clinton Laboratories [Hillsdale / United States of America]

Inspection End Date: December 8, 2000

FEI: 1820381

Location: HILLSDALE, INDIANA, United States of America

Investigators: Leigh Anne Myers, Jeffrey A Sommers

Alpha Therapeutic Corporation [Memphis / United States of America]

Inspection End Date: December 8, 2000

FEI: 1046595

Location: MEMPHIS, TENNESSEE, United States of America

Investigators: Joan A Loreng, Brian S Lynch, Emily E Smith

Julian L Peskin MD [Cleveland / United States of America]

Inspection End Date: December 8, 2000

FEI: 3003194362

Location: CLEVELAND, OHIO, United States of America

Investigators: Stephen J Kilker

Coulston Foundation [Alamogordo / United States of America]

Inspection End Date: December 8, 2000

FEI: 1640760

Location: ALAMOGORDO, NEW MEXICO, United States of America

Investigators: David L Duncan, Cynthia Jim, CSO

Adven Medical, Inc. [Lubbock / United States of America]

Inspection End Date: December 8, 2000

FEI: 1649663

Location: LUBBOCK, TEXAS, United States of America

Investigators: Monica J Wilkins

GE Medical Systems, SCS [Buc / France]

Inspection End Date: December 8, 2000

FEI: 1000284313

Location: BUC, ÎLE-DE-FRANCE, France

Investigators: Martina E Lagrange

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

Inspection End Date: December 8, 2000

FEI: 2280503

Location: WALL TOWNSHIP, NEW JERSEY, United States of America

Investigators: Byungja E Marciante

Frontida BioPharm, LLC [Philadelphia / United States of America]

Inspection End Date: December 8, 2000

FEI: 2523348

Location: PHILADELPHIA, PENNSYLVANIA, United States of America

Investigators: Jean Blackston Hill, Debra J Bennett

Tera Pharmaceuticals Inc [Buena Park / United States of America]

Inspection End Date: December 8, 2000

FEI: 2021778

Location: BUENA PARK, CALIFORNIA, United States of America

Investigators: Elaine A Bunch, John Cheng (NMI), Diane Cvan Leeuwen, Mihaly S Ligmond, Virgilio F Pacio, CSO

Douer, Dan, M.D. [Los Angeles / United States of America]

Inspection End Date: December 8, 2000

FEI: 3003206067

Location: LOS ANGELES, CALIFORNIA, United States of America

Investigators: Valerie L Whipp

SP Pharmaceuticals LLC [Albuquerque / United States of America]

Inspection End Date: December 8, 2000

FEI: 3003704175

Location: ALBUQUERQUE, NEW MEXICO, United States of America

Investigators: Karen G Hirshfield

Kingman Regional Medical Center [Kingman / United States of America]

Inspection End Date: December 8, 2000

FEI: 2077961

Location: KINGMAN, ARIZONA, United States of America

Investigators: Vien Q Le

Equi-Tox, Inc. [Central / United States of America]

Inspection End Date: December 7, 2000

FEI: 3003215476

Location: CENTRAL, SOUTH CAROLINA, United States of America

Investigators: Stephanie E Hubbard

Micron Technologies, Inc. [Exton / United States of America]

Inspection End Date: December 7, 2000

FEI: 2533247

Location: EXTON, PENNSYLVANIA, United States of America

Investigators: Dr. Mark J Seaton, PhD, Vlada Matusovsky

Amdel [Sydney / Australia]

Inspection End Date: December 7, 2000

FEI: 3003183286

Location: SYDNEY, NEW SOUTH WALES, Australia

Investigators: Robert D Tollefsen, Thomas J Arista

Sulzer Orthopedics, Ltd. [Winterthur / Switzerland]

Inspection End Date: December 7, 2000

FEI: 9613351

Location: WINTERTHUR, ZÜRICH, Switzerland

Investigators: Jacqueline S Warner

Bayer Healthcare Animal Health Inc [Saint Joseph / United States of America]

Inspection End Date: December 7, 2000

FEI: 1000118231

Location: SAINT JOSEPH, MISSOURI, United States of America

Investigators: Susanna E Ford, Margaret A Smithers, Gwyn G Dickinson, Michele Perry Williams

Bayer HealthCare LLC [Berkeley / United States of America]

Inspection End Date: December 7, 2000

FEI: 2910913

Location: BERKELEY, CALIFORNIA, United States of America

Investigators: Ann Marie Montemurro, Omotunde O Osunsanmi, Roman T Drews, PhD, Alicia Gilbert, Jeffrey M Watson, Ann Marie Schofield, Richard W Thornton

Weber Laboratories Inc [Irvine / United States of America]

Inspection End Date: December 7, 2000

FEI: 2027367

Location: IRVINE, CALIFORNIA, United States of America

Investigators: Sue Lee Chan, Mei Chi Siu, Michael S Araneta, Yumi J Hiramine

Otsuka Pharmaceutical Development & Commercialization, Inc [Rockville / United States of America]

Inspection End Date: December 6, 2000

FEI: 3000718406

Location: ROCKVILLE, MARYLAND, United States of America

Investigators: Denis Mackey, Deanne E Knapp, Lori S Lawless

Xellia Pharmaceuticals ApS [København S / Denmark]

Inspection End Date: December 6, 2000

FEI: 3002806860

Location: KØBENHAVN S, HOVEDSTADEN, Denmark

Investigators: David M Beltran, Rochelle K Kimmel

ALK-Abello, Inc [Round Rock / United States of America]

Inspection End Date: December 6, 2000

FEI: 1640000

Location: ROUND ROCK, TEXAS, United States of America

Investigators: Eliezar Ramos, Julie D Bringger

Bigmar Pharmaceuticals Inc [Johnstown / United States of America]

Inspection End Date: December 6, 2000

FEI: 3001238536

Location: JOHNSTOWN, OHIO, United States of America

Investigators: Jeffrey A Sincek, Hugh M Mcclure, II

Perfecto Products Mfg Inc [Atlanta / United States of America]

Inspection End Date: December 6, 2000

FEI: 1039259

Location: ATLANTA, GEORGIA, United States of America

Investigators: Leah M Andrews

F. Hoffmann-La Roche AG [Basel / Switzerland]

Inspection End Date: December 5, 2000

FEI: 3002807200

Location: BASEL, BASEL-STADT, Switzerland

Investigators: Sidney B Priesmeyer

Bayer HealthCare LLC [Morristown / United States of America]

Inspection End Date: December 5, 2000

FEI: 2243252

Location: MORRISTOWN, NEW JERSEY, United States of America

Investigators: Russell J Glapion, Donald L Lech

Northwest Women's Clinic [Portland / United States of America]

Inspection End Date: December 5, 2000

FEI: 3003218226

Location: PORTLAND, OREGON, United States of America

Investigators: Irvine Irvine, James C Henry

Mayne Pharma International Pty Ltd. [Adelaide / Australia]

Inspection End Date: December 5, 2000

FEI: 3004090027

Location: ADELAIDE, SOUTH AUSTRALIA, Australia

Investigators: Robert D Tollefsen, Thomas J Arista

International Bio Resources LLC [Milwaukee / United States of America]

Inspection End Date: December 1, 2000

FEI: 2129501

Location: MILWAUKEE, WISCONSIN, United States of America

Investigators: Lisa M Lopez, Jane E Nelson, Denise L Burosh

Medtronic Neurological - MGU and Emerging Therapies [Saint Paul / United States of America]

Inspection End Date: December 1, 2000

FEI: 1000135098

Location: SAINT PAUL, MINNESOTA, United States of America

Investigators: Christine M Parmentier

Chattem Chemicals, Inc. [Chattanooga / United States of America]

Inspection End Date: December 1, 2000

FEI: 1000524733

Location: CHATTANOOGA, TENNESSEE, United States of America

Investigators: George J Flynn

Community Blood Center Of Gtr Kansas City, An Operating Division of New York Blood Center, Inc. [Kansas City / United States of America]

Inspection End Date: December 1, 2000

FEI: 1972933

Location: KANSAS CITY, MISSOURI, United States of America

Investigators: William F Lagud, Jr, Brenda C Hamilton, Minerva Rogers, David L Miser, Marion D Wimberly, Jr, Dana D Carter, SR DDS

Sunopta [Carson City / United States of America]

Inspection End Date: December 1, 2000

FEI: 2919889

Location: CARSON CITY, NEVADA, United States of America

Investigators: Carl Lee, Juan A Morales

Pacific Fresh Sacramento LLC [Sacramento / United States of America]

Inspection End Date: November 30, 2000

FEI: 1000523158

Location: SACRAMENTO, CALIFORNIA, United States of America

Investigators: Elsa Y Yu, Bruce D Broidy

Natural Biologics Llc [Albert Lea / United States of America]

Inspection End Date: November 30, 2000

FEI: 3001915344

Location: ALBERT LEA, MINNESOTA, United States of America

Investigators: Gregory W Smith, Sharon K Thoma, PharmD

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

Inspection End Date: November 30, 2000

FEI: 2131093

Location: MILWAUKEE, WISCONSIN, United States of America

Investigators: Jeffry A Bernhardt, Denise L Burosh

Walsh Manufacturing [Oakville / Canada]

Inspection End Date: November 30, 2000

FEI: 9612334

Location: OAKVILLE, ONTARIO, Canada

Investigators: Lance D Johnson

Tecres S.p.A. [Sommacampagna / Italy]

Inspection End Date: November 30, 2000

FEI: 3002808402

Location: SOMMACAMPAGNA, VENETO, Italy

Investigators: Jacqueline S Warner

Applied Laboratories, Inc. [Columbus / United States of America]

Inspection End Date: November 30, 2000

FEI: 1831301

Location: COLUMBUS, INDIANA, United States of America

Investigators: Larry K Austin

OneBlood, Inc. [Fort Lauderdale / United States of America]

Inspection End Date: November 30, 2000

FEI: 1077496

Location: FORT LAUDERDALE, FLORIDA, United States of America

Investigators: Ronnie E Jackson

Nancy L. Bartlett, MD [Saint Louis / United States of America]

Inspection End Date: November 30, 2000

FEI: 3003180903

Location: SAINT LOUIS, MISSOURI, United States of America

Investigators: Robert J Nesselhauf

Rush & Hebble Co., Inc. [Edinburgh / United States of America]

Inspection End Date: November 30, 2000

FEI: 1821929

Location: EDINBURGH, INDIANA, United States of America

Investigators: Neal D Singletary, PhD

Bergen Comm Reg Blood Center [Montvale / United States of America]

Inspection End Date: November 29, 2000

FEI: 2275064

Location: MONTVALE, NEW JERSEY, United States of America

Investigators: Diane M Gubernot, Lisa Harlan

Banco de Sangre Humacao, Inc. [Humacao / Puerto Rico]

Inspection End Date: November 28, 2000

FEI: 2677502

Location: HUMACAO, PUERTO RICO, Puerto Rico

Investigators: Dianiris C Ayala

Ochsner Clinic Foundation IRB [New Orleans / United States of America]

Inspection End Date: November 28, 2000

FEI: 2310313

Location: NEW ORLEANS, LOUISIANA, United States of America

Investigators: Dana M Klimavicz, Dana M Daigle

Univ. of Miami, School of Medicine, Dept. of Psychiatry [Miami / United States of America]

Inspection End Date: November 28, 2000

FEI: 300318982

Location: MIAMI, FLORIDA, United States of America

Investigators: Luz I Collado

Novus Fine Chemicals [Carlstadt / United States of America]

Inspection End Date: November 27, 2000

FEI: 2211054

Location: CARLSTADT, NEW JERSEY, United States of America

Investigators: Keith M Reilly, Douglas C Kovacs, Jeffrey J Ebersole

Sato Yakuhin Kogyo Co., Ltd. [Kannonjicho / Japan]

Inspection End Date: November 24, 2000

FEI: 3003183265

Location: KANNONJICHO, NARA, Japan

Investigators: Robert D Tollefsen, Thomas J Arista

Prof. Sante Tura, M.D. [Bologna / Italy]

Inspection End Date: November 23, 2000

FEI: 3002809304

Location: BOLOGNA, EMILIA ROMAGNA, Italy

Investigators: Susan F Laska, MS

Genzyme Corp. [Middleton / United States of America]

Inspection End Date: November 22, 2000

FEI: 1000115830

Location: MIDDLETON, WISCONSIN, United States of America

Investigators: Ronald R Ruff

Alberto Interian, Jr., M.D. [Miami / United States of America]

Inspection End Date: November 22, 2000

FEI: 3003157010

Location: MIAMI, FLORIDA, United States of America

Investigators: Bill Tacket, Jr, Edwin J Gorney, Lt Bill Tackett, Jr, Edward J Gorney

IBA was Steri Genics, Inc. [Charlotte / United States of America]

Inspection End Date: November 22, 2000

FEI: 1058584

Location: CHARLOTTE, NORTH CAROLINA, United States of America

Investigators: Paul W Moy

Scirex Corp [Austin / United States of America]

Inspection End Date: November 22, 2000

FEI: 3002695637

Location: AUSTIN, TEXAS, United States of America

Investigators: Joel D Martinez

Pharmacy Associates Inc [Parkersburg / United States of America]

Inspection End Date: November 21, 2000

FEI: 3001701620

Location: PARKERSBURG, WEST VIRGINIA, United States of America

Investigators: William D Bassett, Jr, William A Warnick

St. Jude Medical [Minneapolis / United States of America]

Inspection End Date: November 21, 2000

FEI: 3000927285

Location: MINNEAPOLIS, MINNESOTA, United States of America

Investigators: Sharon L Matson

Generics Bidco II LLC d/b/a Prinston Laboratories [Charlotte / United States of America]

Inspection End Date: November 21, 2000

FEI: 1038197

Location: CHARLOTTE, NORTH CAROLINA, United States of America

Investigators: Penny H Mccarver, Philip Campbell, Tracy R Ball

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