FDA Investigator Laureen M Geniusz

Laureen M Geniusz has inspections in 12 countries as of 12 Oct 2023. Laureen M Geniusz has collaborated with a combinined 3630 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
305
Last Inspection Date:
12 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100000930
Country:
United States of America, Canada, Costa Rica, Germany, United Kingdom of Great Britain and Northern Ireland, Dominican Republic, Brazil, Austria, Italy, Poland, Sweden
Co-Investigator(s):
A Williams, Aaron J Fox, Adaliz Santaliz Cruz, Aigbokhai A Dirisu, Alice C Silva, Allison C Hunter, Allison E Sincek, Allison M Mcgloin, Allison M Scheck, Amy M Cramer, Amy S Graf, Andrea A Branche, Andrew A Leboeuf, Andrew H Paeng, Andrew J Garufi, Andrew J Lang, Annemarie Kleiza, Ashley A Mutawakkil, Bemjamin J Dastoli, Benjamin J Dastoli, Benjamin J Dstoli, Benjamin J Smith, Benjamin W Anderson, Brian M Campbell, Brian M Marosan, Brigitte K Hofmann, Brigitte Kh Strelnik, Brittany M Kershaw, Brittany M Lowe, Bryan J Love, Byungja E Marciante, Calvin K Cook, Camerson E Moore, Carl A Huffman, III, Carolyn E Barney, Catherine J Laufmann, CDR Sean T Creighton, Chad E Schmear, Charles L Larson, Charles M Spyr, Charles N Dupont, Cherie T Parker, Cheryl D Mccall, Christina L Bigham, Christine E Kelley, Christopher B May, Christopher C Wilcox, Christopher T Middendorf, Clinton D Priestley, Corey K Reno, Corrine M Carter, Craig T Rybus, Creighton T Tuzon, Cynthia L Aycock, Cynthia Li, Cynthia T Cain, Daniel J Lahar, Dannie E Rowland, Darla J Christopher, David J Gasparovich, Debara R Reese, Deborah M Trout, Dell S Moller, Dellarese L Herbert, Diane M Fresch, Dipesh K Shah, Edward D Mcdonald, Edward R Kay, Elizabeth B Griffin, Elizabeth Ll Edwards, Elizabeth P Kinsella, Ellen J Tave, Eric A Mann, Ernest H Blackwood, Felicia E Hinojosa, Frank J Marciniak, Frederick K Lochner, Frederick M Fochner, Frederick M Lochner, Gary Durbiel Goldner, Geoffrey K Kilili, Gina M Brackett, Harperd, Ivan E Reyes, Jacqueline S Warner, James A Beaulieu, James E Frye, James K Kane, PhD, James M Odonnell, James R Evans, James W Leonette, Janet L Bowen, Janet Pulver, Javonica F Penn, Jazmine N Still, Jennifer L Gustavus, Jennifer L Jager, Jennifer L Sheehan, Jocelyn C Turner, Jocelyn E Massey, John E Marszalek, Joseph R Strelnik, Juan A Morales, Juanita Banuelos, Juliane C Lessard, Julie D Bringger, Karen M Kondas, Karen S Anthony, Katelyn Astaub Zamperini, Kathleen D Culver, Kathryn J Mccarty, Kenneth S Boehnen, Kennita Riddick, Kimberly Lewandowski Walker, Kinh Q Mac, Klein, L Rebeccacrk Clark, Lance D Johnson, Larry K Austin, Laurie B Frazier, LCDR Anastasia Mpiliafas Brown, Leo J Lagrotte, Leslie R Clark, Linda A Gregory, Linda Agregory Duty, Lindsey M Schwierjohann, Lisa A Warner, Lisa Hornback, Lori A Carr, Lori A Lahmann, Lori S Lawless, Malik S Qaiser, Marc S Neubauer, Maribeth G Grattan, Maribeth G Niesen, Mark E Parmon, Mary E Storch, Matthew A Humbard, Matthew H Pitts, Matthew W Kyle, Michael E Campbell, Michael E Clark, Michael J Nerz, Michael K Larson, Michael P Sheehan, Minh D Phan, Mishelle L Harriger, Monica J Wilkins, Myra K Casey, Nancy A Bellamy, Nancy L Neiger, Nicholas L Paulin, Norman Wong, Patrick B Cummings, Paul A Bonneau, Paul R Whitby, Paula A Trost, Phillip M Pontikos, Pifer, Raffi B Papazian, Ralph A Erickson, Rebecca Clark, Regina T Brown, Richard Jay Tucker, RS, Richard K Vogel, Robbie J Alleman, Robert G Ruff, Robert W Jennings, Rosanna M Goodrich, Rosanna M Vaccaro, Rosannam Voeearo, Rose M Ashley, Roy Baby, Roy C Stephens, Rterry Bolen, Sargum C Sood, Scott T Ballard, Selene T Torres, Shankar L Saha, Shannon A Gregory, Shannon F Underwood, Sherri J Liu, Shirley H Isbill, Sneha S Patel, Sonya L Karsik, State Agency, Stephen J Kilker, Steven R Ziser, Suyang Qin, Talmane J Fisher, Tamara M Kays, Tania E Garcia, Tania E Vizcaino, Teresa Jimenez, Teresa K Kastner, Terry C Kimball, Thanh M Andrews, Thomas A Peter, Thomas J Arista, Thomas S Arista, Thunder N Dunkijacobs, Tiki J Dixon, William D Tingley, William R Brubaker, William Regnault, PhD, Yehualashet A Gessesse

Laureen M Geniusz's Documents

Publish Date Document Type Title
April, 2012 FDA 483 Sparton Medical - Form 483, 2012-04-12
December, 2009 FDA 483 Orthohelix Surgical Designs Inc - Form 483, 2009-12-11
April, 2011 FDA 483 Applied Medical Technology Inc - Form 483, 2011-04-29
May, 2003 FDA 483 Perkinelmer Las Inc - Form 483, 2003-05-16
April, 2009 FDA 483 Research Instrumentation Associates Inc - Form 483, 2009-04-22
June, 2003 FDA 483 Western / Scott Fetzer Company - Form 483, 2003-06-20
November, 2010 FDA 483 OsteoSymbionics LLC - Form 483, 2010-11-03
May, 2000 EIR Invacare Corporation - EIR, 2000-05-16
June, 2019 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2019-06-04
May, 2003 FDA 483 Response Perkinelmer Las Inc - Form 483R, 2003-05-30
June, 2011 FDA 483 Cleveland Medical Devices Inc - Form 483, 2011-06-01
March, 2018 FDA 483 Response Checkpoint Surgical Inc - Form 483R, 2018-04-04
August, 2013 FDA 483 RSB Spine LLC - Form 483, 2013-08-06
October, 2019 FDA 483 Valtronic Technologies Inc. - Form 483, 2019-10-29
June, 2001 EIR MED-EL Elektromedizinische Gereate, Gmbh - EIR, 2001-06-22
October, 2002 EIR Invacare Corporation - EIR, 2002-10-17
June, 2012 FDA 483 HMI Industries Inc - Form 483, 2012-06-04
February, 2002 FDA 483 Bard Endoscopic Technologies - Form 483, 2002-02-28
January, 2018 EIR Bio-Thesiometer USA - EIR, 2018-01-19
February, 2003 EIR Steris Corporation - EIR, 2003-02-14
June, 2014 FDA 483 HMI Industries Inc - Form 483, 2014-06-25
May, 2002 FDA 483 MPW Industrial Services Inc. - Form 483, 2002-05-08
September, 2003 FDA 483 Braebon Medical Corp. - Form 483, 2003-09-16
November, 2018 FDA 483 Kapp Surgical Instrument Inc - Form 483, 2018-11-16
July, 2019 FDA 483 Alltech Medical Systems America Inc - Form 483, 2019-07-29
February, 2015 FDA 483 Cleveland Medical Devices Inc - Form 483, 2015-02-05
August, 2001 FDA 483 Perkinelmer Las Inc - Form 483, 2001-08-24
August, 2001 EIR Perkinelmer Las Inc - EIR, 2001-08-24
November, 2003 FDA 483 Perkinelmer Las Inc - Form 483, 2003-11-05
January, 2014 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2014-01-28
April, 2017 FDA 483 Remel Inc. - Form 483, 2017-04-12
September, 2023 FDA 483 CIT Ortho - Form 483, 2023-09-05
March, 2018 EIR Checkpoint Surgical Inc - EIR, 2018-03-15
October, 2008 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2008-10-30
April, 2011 FDA 483 Neurowave Systems Inc - Form 483, 2011-04-04
June, 2021 FDA 483 Invacare Corporation - Form 483, 2021-06-24
February, 2000 FDA 483 Gliatech, Inc. - Form 483, 2000-02-23
October, 2011 FDA 483 Norman Noble Inc - Form 483, 2011-10-12
November, 2011 FDA 483 OsteoSymbionics LLC - Form 483, 2011-11-03
October, 2009 FDA 483 Frantz Medical Development Ltd. - Form 483, 2009-10-28
June, 2015 FDA 483 Transdermal Cap Inc. - Form 483, 2015-06-30
June, 2001 EIR Amresco LLC - EIR, 2001-06-14
August, 2003 FDA 483 Western / Scott Fetzer Company - Form 483, 2003-08-29
July, 2012 FDA 483 Scottcare Corporation - Form 483, 2012-07-26
June, 2012 EIR St. Jude Medical Costa Rica Ltda - EIR, 2012-06-21
August, 2002 FDA 483 Walsh Medical Devices Inc. - Form 483, 2002-08-01
May, 2006 FDA 483 Radiometer America Inc - Form 483, 2006-05-25
September, 2011 FDA 483 Norman Noble Inc - Form 483, 2011-09-09
August, 2017 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2017-08-18
August, 2016 FDA 483 Western / Scott Fetzer Company - Form 483, 2016-08-12
June, 2012 EIR Allergan Corporation Costa Rica - EIR, 2012-06-15
November, 2011 FDA 483 Gentherm Medical, LLC - Form 483, 2011-11-18
June, 2017 FDA 483 Invacare Corporation - Form 483, 2017-06-16
May, 2010 FDA 483 SpineMatrix Inc - Form 483, 2010-05-07
March, 2016 FDA 483 Avery Dennison Corp/Avery Dennison Medical - Form 483, 2016-03-11
March, 2023 FDA 483 Invacare Corporation - Form 483, 2023-03-30
September, 2009 FDA 483 New Leaf Medical Inc - Form 483, 2009-09-16
November, 2019 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2019-11-26
December, 2015 FDA 483 Invacare Corporation - Form 483, 2015-12-09
October, 2000 FDA 483 Cleveland Medical Devices, INC. - Form 483, 2000-10-20
February, 2003 FDA 483 Response Steris Corporation - Form 483R, 2003-02-28
September, 2014 FDA 483 Western / Scott Fetzer Company - Form 483, 2014-09-02
December, 2016 FDA 483 US Endoscopy Group Inc - Form 483, 2016-12-07
June, 2015 FDA 483 Response Transdermal Cap Inc. - Form 483R, 2015-07-15
June, 2011 FDA 483 HMI Industries Inc - Form 483, 2011-06-29
January, 2020 FDA 483 Invacare Corporation - Form 483, 2020-01-31
March, 2012 FDA 483 Neogenix, LLC - Form 483, 2012-03-01
June, 2015 FDA 483 NDI Medical LLC - Form 483, 2015-06-02
March, 2017 FDA 483 OsteoSymbionics LLC - Form 483, 2017-03-29
October, 2002 FDA 483 Invacare Corporation - Form 483, 2002-10-17
July, 2002 EIR NeuroControl Corp - EIR, 2002-07-12
February, 2003 FDA 483 Steris Corporation - Form 483, 2003-02-14
December, 2000 FDA 483 Gliatech Inc - Form 483, 2000-12-19
August, 2001 FDA 483 Cleveland Medical Devices Inc - Form 483, 2001-08-09
February, 2001 EIR NeuroControl Corp - EIR, 2001-02-15
August, 2009 FDA 483 SpineMatrix Inc - Form 483, 2009-08-27
May, 2013 FDA 483 Transdermal Cap Inc. - Form 483, 2013-05-29
August, 2002 FDA 483 Pemco Inc - Form 483, 2002-08-23
March, 2015 FDA 483 Radiometer America Inc - Form 483, 2015-03-02
March, 2017 FDA 483 Marlen Manufacturing & Development Co. - Form 483, 2017-03-13
February, 2011 FDA 483 Innovative Medical Equipment - Form 483, 2011-02-15
January, 2013 FDA 483 Orthohelix Surgical Designs Inc - Form 483, 2013-01-31
September, 2010 FDA 483 R4 LLC - Form 483, 2010-09-20
February, 2002 EIR Ben Venue Laboratories Inc. - EIR, 2002-02-01
December, 2010 FDA 483 Apteryx Inc - Form 483, 2010-12-03
May, 2010 FDA 483 RSB Spine LLC - Form 483, 2010-05-21
September, 2018 FDA 483 Frantz Medical Development Ltd. - Form 483, 2018-09-24
June, 2003 EIR Western / Scott Fetzer Company - EIR, 2003-06-20
January, 2017 FDA 483 Zuga Medical Inc. - Form 483, 2017-01-27
May, 2009 FDA 483 X Spine Systems Inc - Form 483, 2009-05-07
March, 2011 FDA 483 NDI Medical LLC - Form 483, 2011-03-03
August, 2018 FDA 483 Western / Scott Fetzer Company - Form 483, 2018-08-29
November, 2005 FDA 483 Roche Diagnostics Operations, Inc. - Form 483, 2005-11-04
March, 2010 FDA 483 Remel Inc. - Form 483, 2010-03-16
February, 2002 FDA 483 Miltronics & Skye Inc. - Form 483, 2002-02-08
May, 2014 FDA 483 Zuga Medical Inc. - Form 483, 2014-05-16
November, 2007 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2007-12-18
September, 2014 FDA 483 Norman Noble Inc - Form 483, 2014-09-30
February, 2008 FDA 483 National Biological Corp - Form 483, 2008-02-27
October, 2017 FDA 483 Scottcare Corporation - Form 483, 2017-10-05
February, 2001 FDA 483 NeuroControl Corporation - Form 483, 2001-02-15
March, 2015 EIR MIM Software Inc - EIR, 2015-03-27
December, 2014 FDA 483 Synapse Biomedical Inc - Form 483, 2014-12-05
January, 2014 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2014-01-28
June, 2003 EIR Western / Scott Fetzer Company - EIR, 2003-06-17
November, 2006 EIR Tiara Medical Systems, Inc. - EIR, 2006-11-03
March, 2013 FDA 483 Gebauer Company - Form 483, 2013-03-26
December, 2018 FDA 483 Valtronic Technologies Inc. - Form 483, 2018-12-19
March, 2015 FDA 483 MIM Software Inc - Form 483, 2015-03-27
September, 2000 FDA 483 Steris Corporation - Form 483, 2000-09-15
August, 2003 EIR Western / Scott Fetzer Company - EIR, 2003-08-29
March, 2018 FDA 483 Checkpoint Surgical Inc - Form 483, 2018-03-15
January, 2012 FDA 483 Gebauer Company - Form 483, 2012-01-26
October, 2020 FDA 483 Synapse Biomedical Inc - Form 483, 2020-10-07
February, 2017 FDA 483 Surgical Theater Inc - Form 483, 2017-02-23
December, 2012 FDA 483 Norman Noble Inc - Form 483, 2012-12-13
September, 2005 FDA 483 Theken Companies LLC - Form 483, 2005-09-09
February, 2010 FDA 483 Tech Industries Inc - Form 483, 2010-02-11
June, 2009 FDA 483 Volk Optical Inc - Form 483, 2009-06-26
June, 2009 FDA 483 Scottcare Corporation - Form 483, 2009-06-17
June, 2019 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2019-07-03
November, 2021 FDA 483 Cleveland Diagnostics, Inc - Form 483, 2021-11-10
March, 2020 FDA 483 Steris Corporation - Form 483, 2020-03-13
February, 2018 FDA 483 SPR Therapeutics Inc. - Form 483, 2018-02-22
June, 2001 FDA 483 Amresco LLC - Form 483, 2001-06-14
January, 2015 FDA 483 Great Lakes Neurotechnologies Inc - Form 483, 2015-01-13
August, 2017 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2017-08-18
January, 2011 FDA 483 American Contract Systems Inc - Form 483, 2011-01-14
December, 2010 FDA 483 New Leaf Medical Inc - Form 483, 2010-12-06
June, 2003 FDA 483 Response Western / Scott Fetzer Company - Form 483R, 2003-10-08
February, 2023 FDA 483 Criterion Tool & Die Inc - Form 483, 2023-02-17
September, 2013 FDA 483 Lucero Medical LLC - Form 483, 2013-09-12
April, 2001 FDA 483 Pemco Inc - Form 483, 2001-04-19
January, 2018 FDA 483 Bio-Thesiometer USA - Form 483, 2018-01-19
June, 2023 FDA 483 Frantz Medical Development Ltd. - Form 483, 2023-06-27

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