FDA Investigator Laureen M Geniusz

Laureen M Geniusz has conducted inspections on 309 sites in 11 countries as of 05 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
309
Last Inspection Date:
05 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100000930
Countries of Inspections:
United States of America, Canada, Costa Rica, Italy, Brazil, Germany, United Kingdom of Great Britain and Northern Ireland, Austria, Dominican Republic, Poland, Sweden
FDA Investigators that have inspected at least one site in common with Laureen M Geniusz:
Aaron J Fox, Adaliz Santaliz Cruz, Aigbokhai A Dirisu, Alice C Silva, Allison C Hunter, Allison E Sincek, Allison M Mcgloin, Allison M Scheck, Althea A Williams, 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, Benjamin J Dastoli, 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, Dolores Harper, Ebony D Sanon, 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 Armbrustmacher, Felicia E Hinojosa, Frank J Marciniak, Frederick M Lochner, Gamal A Norton, Gary Durbiel Goldner, Geoffrey K Kilili, Gina M Brackett, 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, L Rebeccacrk Clark, Lance D Johnson, Larry K Austin, Laurie B Frazier, LCDR Anastasia M Piliafas Brown, Leo J Lagrotte, Leslie R Clark, Linda A Gregory 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 Cburgos Garcia, Monica J Wilkins, Myra K Casey, Nancy A Bellamy, Nancy L Neiger, Nicholas L Paulin, Norman Wong, Paranthaman Senthamaraikannan, 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 Jennings, Rosanna M Goodrich, Rosanna M Vaccaro, Rose 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, RAC, 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, 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
September, 2013 FDA 483 Lucero Medical LLC - Form 483, 2013-09-12
June, 2017 FDA 483 Invacare Corporation - Form 483, 2017-06-16
June, 2011 FDA 483 Health-Mor, Inc - Form 483, 2011-06-29
February, 2002 FDA 483 Miltronics & Skye Inc. - Form 483, 2002-02-08
November, 2005 FDA 483 Roche Diagnostics Operations, Inc. - Form 483, 2005-11-04
August, 2016 FDA 483 Western / Scott Fetzer Company - Form 483, 2016-08-12
January, 2011 FDA 483 American Contract Systems Inc - Form 483, 2011-01-14
January, 2015 FDA 483 Great Lakes Neurotechnologies Inc - Form 483, 2015-01-13
September, 2014 FDA 483 Western / Scott Fetzer Company - Form 483, 2014-09-02
September, 2005 FDA 483 Theken Companies LLC - Form 483, 2005-09-09
June, 2015 FDA 483 Response Transdermal Cap Inc. - Form 483R, 2015-07-15
December, 2010 FDA 483 New Leaf Medical Inc - Form 483, 2010-12-06
December, 2023 FDA 483 Ekso Bionics Inc. - Form 483, 2023-12-21
May, 2013 FDA 483 Transdermal Cap Inc. - Form 483, 2013-05-29
October, 2000 FDA 483 Cleveland Medical Devices Inc - Form 483, 2000-10-20
March, 2015 FDA 483 MIM Software Inc - Form 483, 2015-03-27
June, 2001 FDA 483 Amresco LLC - Form 483, 2001-06-14
March, 2023 FDA 483 Invacare Corporation - Form 483, 2023-03-30
September, 2009 FDA 483 New Leaf Medical Inc - Form 483, 2009-09-16
June, 2009 FDA 483 Scottcare Corporation - Form 483, 2009-06-17
April, 2001 FDA 483 Pemco Inc - Form 483, 2001-04-19
February, 2003 FDA 483 Steris Corporation - Form 483, 2003-02-14
August, 2001 FDA 483 Cleveland Medical Devices Inc - Form 483, 2001-08-09
March, 2017 FDA 483 OsteoSymbionics LLC - Form 483, 2017-03-29
February, 2002 FDA 483 Bard Endoscopic Technologies - Form 483, 2002-02-28
October, 2002 FDA 483 Invacare Corporation - Form 483, 2002-10-17
January, 2017 FDA 483 Zuga Medical Inc. - Form 483, 2017-01-27
September, 2000 FDA 483 Steris Corporation - Form 483, 2000-09-15
January, 2018 FDA 483 Bio-Thesiometer USA - Form 483, 2018-01-19
June, 2001 EIR MED-EL Elektromedizinische Gereate, Gmbh - EIR, 2001-06-22
August, 2002 FDA 483 Pemco Inc - Form 483, 2002-08-23
December, 2000 FDA 483 Gliatech Inc - Form 483, 2000-12-19
December, 2018 FDA 483 Valtronic Technologies Inc. - Form 483, 2018-12-19
February, 2010 FDA 483 Tech Industries Inc - Form 483, 2010-02-11
February, 2001 EIR NeuroControl Corp - EIR, 2001-02-15
April, 2011 FDA 483 Neurowave Systems Inc - Form 483, 2011-04-04
August, 2002 FDA 483 Walsh Medical Devices Inc. - Form 483, 2002-08-01
July, 2012 FDA 483 Scottcare Corporation - Form 483, 2012-07-26
February, 2003 FDA 483 Response Steris Corporation - Form 483R, 2003-02-28
June, 2012 EIR Abbott Medical Costa Rica Ltda - EIR, 2012-06-21
June, 2003 FDA 483 Western / Scott Fetzer Company - Form 483, 2003-06-20
April, 2011 FDA 483 Applied Medical Technology Inc - Form 483, 2011-04-29
June, 2011 FDA 483 Cleveland Medical Devices Inc - Form 483, 2011-06-01
May, 2003 FDA 483 Response Perkinelmer Las Inc - Form 483R, 2003-05-30
May, 2003 FDA 483 Perkinelmer Las Inc - Form 483, 2003-05-16
May, 2009 FDA 483 X Spine Systems Inc - Form 483, 2009-05-07
May, 2010 FDA 483 SpineMatrix Inc - Form 483, 2010-05-07
November, 2011 FDA 483 OsteoSymbionics LLC - Form 483, 2011-11-03
November, 2011 FDA 483 Gentherm Medical, LLC - Form 483, 2011-11-18
November, 2019 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2019-11-26
October, 2011 FDA 483 Norman Noble Inc - Form 483, 2011-10-12
January, 2018 EIR Bio-Thesiometer USA - EIR, 2018-01-19
April, 2009 FDA 483 Research Instrumentation Associates Inc - Form 483, 2009-04-22
May, 2006 FDA 483 Radiometer America Inc - Form 483, 2006-05-25
June, 2015 FDA 483 Transdermal Cap Inc. - Form 483, 2015-06-30
March, 2010 FDA 483 Remel Inc. - Form 483, 2010-03-16
June, 2003 EIR Western / Scott Fetzer Company - EIR, 2003-06-20
October, 2009 FDA 483 Frantz Medical Development Ltd. - Form 483, 2009-10-28
March, 2016 FDA 483 Avery Dennison Corp/Avery Dennison Medical - Form 483, 2016-03-11
August, 2003 FDA 483 Western / Scott Fetzer Company - Form 483, 2003-08-29
June, 2012 EIR Allergan Corporation Costa Rica - EIR, 2012-06-15
December, 2016 FDA 483 US Endoscopy Group Inc - Form 483, 2016-12-07
December, 2015 FDA 483 Invacare Corporation - Form 483, 2015-12-09
November, 2021 FDA 483 Cleveland Diagnostics, Inc - Form 483, 2021-11-10
March, 2017 FDA 483 Marlen Manufacturing & Development Co. - Form 483, 2017-03-13
June, 2001 EIR Amresco LLC - EIR, 2001-06-14
March, 2011 FDA 483 NDI Medical LLC - Form 483, 2011-03-03
August, 2009 FDA 483 SpineMatrix Inc - Form 483, 2009-08-27
March, 2012 FDA 483 Neogenix, LLC - Form 483, 2012-03-01
February, 2000 FDA 483 Gliatech, Inc. - Form 483, 2000-02-23
August, 2018 FDA 483 Western / Scott Fetzer Company - Form 483, 2018-08-29
July, 2002 EIR NeuroControl Corp - EIR, 2002-07-12
September, 2010 FDA 483 R4 LLC - Form 483, 2010-09-20
June, 2015 FDA 483 NDI Medical LLC - Form 483, 2015-06-02
August, 2017 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2017-08-18
March, 2018 FDA 483 Checkpoint Surgical Inc - Form 483, 2018-03-15
January, 2012 FDA 483 Gebauer Company - Form 483, 2012-01-26
February, 2002 EIR Ben Venue Laboratories Inc. - EIR, 2002-02-01
June, 2019 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2019-07-03
August, 2003 EIR Western / Scott Fetzer Company - EIR, 2003-08-29
June, 2003 EIR Western / Scott Fetzer Company - EIR, 2003-06-17
February, 2017 FDA 483 Surgical Theater Inc - Form 483, 2017-02-23
March, 2015 FDA 483 Radiometer America Inc - Form 483, 2015-03-02
February, 2023 FDA 483 Criterion Tool & Die Inc - Form 483, 2023-02-17
January, 2014 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2014-01-28
December, 2014 FDA 483 Synapse Biomedical Inc - Form 483, 2014-12-05
August, 2017 EIR Philips Medical Systems (Cleveland) Inc - EIR, 2017-08-18
June, 2023 FDA 483 Frantz Medical Development Ltd. - Form 483, 2023-06-27
November, 2007 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2007-12-18
January, 2013 FDA 483 Orthohelix Surgical Designs Inc - Form 483, 2013-01-31
June, 2014 FDA 483 Health-Mor, Inc - Form 483, 2014-06-25
February, 2015 FDA 483 Cleveland Medical Devices Inc - Form 483, 2015-02-05
June, 2021 FDA 483 Invacare Corporation - Form 483, 2021-06-24
September, 2014 FDA 483 Norman Noble Inc - Form 483, 2014-09-30
May, 2000 EIR Invacare Corporation - EIR, 2000-05-16
September, 2003 FDA 483 Braebon Medical Corp. - Form 483, 2003-09-16
September, 2011 FDA 483 Norman Noble Inc - Form 483, 2011-09-09
October, 2019 FDA 483 Valtronic Technologies Inc. - Form 483, 2019-10-29
October, 2017 FDA 483 Scottcare Corporation - Form 483, 2017-10-05
January, 2020 FDA 483 Invacare Corporation - Form 483, 2020-01-31
October, 2002 EIR Invacare Corporation - EIR, 2002-10-17
December, 2010 FDA 483 Apteryx Inc - Form 483, 2010-12-03
March, 2018 FDA 483 Response Checkpoint Surgical Inc - Form 483R, 2018-04-04
December, 2009 FDA 483 Orthohelix Surgical Designs Inc - Form 483, 2009-12-11
May, 2010 FDA 483 RSB Spine LLC - Form 483, 2010-05-21
June, 2012 FDA 483 Health-Mor, Inc - Form 483, 2012-06-04
August, 2013 FDA 483 RSB Spine LLC - Form 483, 2013-08-06
November, 2010 FDA 483 OsteoSymbionics LLC - Form 483, 2010-11-03
October, 2020 FDA 483 Synapse Biomedical Inc - Form 483, 2020-10-07
July, 2019 FDA 483 Alltech Medical Systems America Inc - Form 483, 2019-07-29
April, 2012 FDA 483 Sparton Medical - Form 483, 2012-04-12
May, 2002 FDA 483 MPW Industrial Services Inc. - Form 483, 2002-05-08
December, 2012 FDA 483 Norman Noble Inc - Form 483, 2012-12-13
May, 2014 FDA 483 Zuga Medical Inc. - Form 483, 2014-05-16
February, 2003 EIR Steris Corporation - EIR, 2003-02-14
June, 2003 FDA 483 Response Western / Scott Fetzer Company - Form 483R, 2003-10-08
November, 2018 FDA 483 Kapp Surgical Instrument Inc - Form 483, 2018-11-16
September, 2023 FDA 483 CIT Ortho - Form 483, 2023-09-05
August, 2001 FDA 483 Perkinelmer Las Inc - Form 483, 2001-08-24
February, 2011 FDA 483 Innovative Medical Equipment - Form 483, 2011-02-15
March, 2018 EIR Checkpoint Surgical Inc - EIR, 2018-03-15
June, 2009 FDA 483 Volk Optical Inc - Form 483, 2009-06-26
March, 2020 FDA 483 Steris Corporation - Form 483, 2020-03-13
February, 2018 FDA 483 SPR Therapeutics Inc. - Form 483, 2018-02-22
August, 2001 EIR Perkinelmer Las Inc - EIR, 2001-08-24
February, 2001 FDA 483 NeuroControl Corporation - Form 483, 2001-02-15
September, 2018 FDA 483 Frantz Medical Development Ltd. - Form 483, 2018-09-24
November, 2006 EIR Tiara Medical Systems, Inc. - EIR, 2006-11-03
March, 2013 FDA 483 Gebauer Company - Form 483, 2013-03-26
October, 2008 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2008-10-30
November, 2003 FDA 483 Perkinelmer Las Inc - Form 483, 2003-11-05
June, 2019 FDA 483 Philips Medical Systems (Cleveland) Inc - Form 483, 2019-06-04
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
March, 2015 EIR MIM Software Inc - EIR, 2015-03-27
February, 2008 FDA 483 National Biological Corp - Form 483, 2008-02-27
May, 2024 FDA 483 Viscus Biologics LLC - Form 483, 2024-05-09
March, 2024 FDA 483 VisionAir Solutions LLC - Form 483, 2024-03-14
June, 2024 FDA 483 Health-Mor, Inc - Form 483, 2024-06-14

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