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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