FDA Investigator Sharon I Gundersen

Sharon I Gundersen has conducted inspections on 108 sites in 7 countries as of 29 Aug 2016. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
108
Last Inspection Date:
29 Aug 2016
Investigator Role:
FDA Investigator
Redica ID:
100003900
Countries of Inspections:
United States of America, Finland, Netherlands, Germany, France, Austria, United Kingdom of Great Britain and Northern Ireland
FDA Investigators that have inspected at least one site in common with Sharon I Gundersen:
Abby M Miller, Althea A Williams, Amy M Cramer, Anderson, Andrew K Haack, PhD, Anita Narula, PhD, Arie C Menachem, Arthur S Williams, Jr, Ashleigh P Barkans, Astrida B Mattson, Bradley E Tufto, Brandi L Garbutt, Brenda K Alford, Brenda L Reihing, Brian R Hendricks, Bryce E Mansfield, Burnell M Henry, Camille Bennett Hoffman, Carl A Anderson, Catherine J Laufmann, Ce'nedra M Martin, Charles L Larson, Christina V Santos, Christine M Parmentier, Christopher R Czajka, Christopher S Genther, Connie P Rezendes, Cynthia L Gorveatt, Daniel A Congdon, David H Engelskirchen, David P Vanhouten, Dawn E Barkans, Deborah A Nebenzahl, Dennis G Kawabata, Dennis R Hudson, Devon M Shoop, Dianne B Latona, Dirk L Lincoln, Dolores E Price, Dolores Harper, Dr. Guang Gao, PhD, Emil P Wang, JD, Eric C Fox, Eric C Milstead, Eric L Scott, Finn A Slizza, Gene D Arcy, Gerard Pde Leon, Gordon T Wales, Graham N Giesen, Gregson A Joseph, Harmon M Blanch, Heika R Tait, Herminio C Francisco, Hugh A Grimoldby, Ian J Thomson, James A Lane, James D Hildreth, James E Trabert, James I Vik, James R Fleckenstein, James R Montero, Jane M Kreis, Jean Brewer, Jeanne M Weishaar, Jennifer S Ness, Jenny L Chisem, Jenny L Mccardell, Jessica B Clark, Jessica L Friedt, Jinkee Mvila Binayug, John A Hall, John E Emmert, John W Banks, Jonathan T Little, Joshua J Silvestri, Juanita Banuelos, Juanj N Wu, Julia E Chervoni, Julian C Hanson, K Gonzlez, Karen M Rodriguez, Kari M Johansen, Katherine L Arnold, Kelvin Cheung, Kevin T Gerrity, Kimberly Jproctor Jones, Kun C Liu, Lawrence Y Lee, PhD, Leonard H Lavi, Lewis K Antwi, Linda S Leja, Lisa A Bowden, Lori J Silverstein, Margo C Jones, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Mark E Imsland, Mark L Collins, Mark S Crippen, Mark W Babbitt, Marsha L Mccauley, Matthew M Vernon, Michael D Garcia, Michael F Schuette, Michael Garcia, Mihaly S Ligmond, Mikel T Wright, Msdap Gonzlezk, Nancy A Saxenian Emmons, Neil J Traaen, Norman Wong, Omotunde O Osunsanmi, Orval D Mcintire, Patrick R Brown, Paul M Kawamoto, Paula A Trost, Paula J Wilkerson, Peter Kessler, PhD, Philip E Ake, Phillip M Pontikos, Prabhu P Raju, Randy L Self, Rebecca A Sletner, Rebecca T Davis, Richard G Runyon, Richard Jay Tucker, RS, Rocco C Black, Rosanna M Goodrich, S Lori Brown, PhD MPH, Sandra K Wangen, Sangeeta M Khurana, PhD, Sara Jdent Acosta, Sarah A Hassas, Scott K Zika, Scott W Fox, Selene T Torres, Sharon L Shane, Shelagh D Schopen, Sherri N Rohlf, MD, Stanley B Eugene, BS, BME, Stephen R Souza, Sunitha K Rajaram, PhD, Susan T Hadman, Tara A Marshall, Tara M Pianko, Teresa K Kastner, Terri E Gibson, Terri L Dodds, Thanh M Andrews, Thomas E Friel, Trudy R Papson, Tyler R Courtney, V Teres Speer, Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Veronica L Bush, Vickie L Anderson, Victor A Meo, Virgilio F Pacio, CSO, Xiaojun Yan, Yehualashet A Gessesse, Yvette E Guillermo, Yvonne M Larsen

Sharon I Gundersen's Documents

Publish Date Document Type Title
July, 2016 FDA 483 Natus Medical Incorporated - Form 483, 2016-07-27
June, 2015 FDA 483 Response Physio-Control, Inc. - Form 483R, 2015-07-20
June, 2014 EIR Arifulla Khan MD - EIR, 2014-06-11
February, 2012 FDA 483 Natus Medical Incorporated - Form 483, 2012-02-07
May, 2012 FDA 483 InBios International, Inc. - Form 483, 2012-05-04
October, 2015 FDA 483 Evergreen Orthopedic Research Lab, LLC dba Opertiv - Form 483, 2015-10-29
January, 2014 FDA 483 Pro Trainers' Choice Company, Inc. - Form 483, 2014-01-22
July, 2012 FDA 483 Gynex Corporation - Form 483, 2012-07-20
May, 2014 FDA 483 Cenorin, LLC - Form 483, 2014-05-02
March, 2015 FDA 483 Ocular Instruments, Inc. - Form 483, 2015-03-12
July, 2015 FDA 483 American Benchmark Machine Works, LLC - Form 483, 2015-07-23
April, 2012 FDA 483 Spacelabs Healthcare Inc - Form 483, 2012-04-18
April, 2013 FDA 483 InBios International, Inc. - Form 483, 2013-04-22
August, 2016 FDA 483 Breast Microseed Inc - Form 483, 2016-08-22
March, 2013 FDA 483 Spentech, Inc. - Form 483, 2013-03-19
April, 2016 FDA 483 Virginia Mason Medical Center - Form 483, 2016-04-15
December, 2011 FDA 483 Micro Current Technology, Inc. - Form 483, 2011-12-02
October, 2012 FDA 483 Custom Ocular Prosthetics - Form 483, 2012-10-04
September, 2014 FDA 483 Varaya Photoceuticals LLC - Form 483, 2014-09-16
June, 2014 FDA 483 Innominata LLC, DBA Genbio - Form 483, 2014-06-13
December, 2014 FDA 483 STARMEDTEC GMBH - Form 483, 2014-12-18
October, 2012 FDA 483 D E Hokanson Inc - Form 483, 2012-10-30
June, 2015 FDA 483 Physio-Control, Inc. - Form 483, 2015-06-26
February, 2014 FDA 483 Viramed Biotech AG - Form 483, 2014-02-06
April, 2015 FDA 483 DENTAL ALLIANCE HOLDINGS LLC - Form 483, 2015-04-02
July, 2013 FDA 483 CMR Naviscan Corporation - Form 483, 2013-07-31
June, 2014 FDA 483 Arifulla Khan MD - Form 483, 2014-06-11
March, 2015 FDA 483 Electrical Geodesics, Inc. - Form 483, 2015-03-27
June, 2014 FDA 483 Acon Laboratories, Inc. - Form 483, 2014-06-11

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