FDA Investigator Thea C Grome

Thea C Grome has conducted inspections on 83 sites in 7 countries as of 14 Oct 2020. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
83
Last Inspection Date:
14 Oct 2020
Investigator Role:
FDA Investigator
Redica ID:
100003993
Countries of Inspections:
United States of America, India, Netherlands, Poland, Malaysia, Mexico, Israel
FDA Investigators that have inspected at least one site in common with Thea C Grome:
Adam S Freeman, Alanna L Mussawwir Bias, Alexander M Kay, Alexandria L Capuano, Alford R Taylor, Alla Dubrovsky, Althea A Williams, Amanda E Lewin, PhD, Anderson, Andrea A Branche, Andrea George, PhD, Angel K Sandhu, Angela Shepas, Anh M Lac, Anthony E Keller, RPh, Arindam Dasgupta, PhD, Ashar P Parikh, Barbara A Crowl, Barbara J Wilcox, PhD, Brian R Hendricks, Brittany D Mccracken, Calvin B Koerner, Carl Lee, Carole L Jones, CDR Rochelle B Young, RPh, MSA, CDR Sean T Creighton, Celeta S Coves, Charles A Snipes, PhD, Christine M Parmentier, Christopher R Czajka, Christopher W Buser, Cindy W Lewis, Courtney N Long, Craig A Garmendia, Cynthia J Tsui, Daniel J Lahar, Daniel J Roberts, Daniel L Aisen, Darlene B Almogela, David G Eng, Deborah A Nebenzahl, Dolores Harper, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Zhou Chen (nmi), MD PhD, Dustin P Tran, Dustin R Abaonza, Dylan D Yao, MD, PhD, Edward D Harris, Edward D Vains, Elizabeth A Dakan, Emily Shacter, Eric J Heinze, Eric L Dong, BS, Eric W Anderson, Gene D Arcy, Geoffrey K Kilili, Gerald Feldman, Gerald M Feldman, PhD, Gerald N Mcgirl, DDS, Greg K Keshishyan, Henry K Lau, Himanshu Gupta, PhD, Humberto Z Gomez, Ivar J Sohn, James A Lane, James R Evans, James R Fleckenstein, Jane M Kreis, Janet Pulver, Janete F Guardia, Jeanne Fringer, PhD, Jeanne J Thai, Jeffrey M Watson, Jeffrey S Buckser, Jeffrey W Shrifter, DPM, Jennifer C Adams, Jennifer L Degroot, Jennifer L Johnson, Jessica E Paulsen, Joan T Briones, Jocelyn T Ramos, Joey V Quitania, Joseph A Seitz, III, Joseph Kutze, PhD, Joseph P Iser, MD, Joshua S Hunt, Juan A Morales, Juanita Banuelos, Jude C Dikes, Jyoti B Patel, PhD, Kara A Scheibner, PhD, Karen J Bak, Katlin N Stubbs, Kellia N Hicks, Kelvin Cheung, Kendra A Biddick, Kenya Destin, Keren Arkin, Kevin P Foley, Kristin M Abaonza, Lakecha N Lewis, Lakisha M Williams, Lance A Finnical, Lance Mde Souza, MBA, Laree A Tracy, Laurie P Norwood, Lavender M Huskey, Laverne Puckett, LCDR Jennifer H Rhyu, Leonard H Lavi, Linda Linh N Adams, Linh Tu, Lori A Gioia, Lori J Silverstein, Lucila B Nwatu, Lydia S Chan, Mabel M Lee, Maida Henesian (NMI), Marie K Kinkade, Mariza M Jafary, Mark E Chan, Mark W Babbitt, Marsha W Major, Mary R Hole, Mathew T Thomas, MD, Matthew M Vernon, Melissa A Torres, Melkamu Getie Kebtie, PhD, Mendoza O Wallace, Michael Shanks, MS, Michael T Cyrus, Michelle Rfrazier Jessen, PhD, Mihaly S Ligmond, Min Shanmabel Liu, Mohsen Rajabi Abhari, FDA, Nayan J Patel, Nicholas L Hunt, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole M Bell, Nicole M Gillette, Omotunde O Osunsanmi, Paul M Kawamoto, Paula J Bretz, Peter E Baker, Peter Kessler, PhD, Quynh H Strandberg, Quynh Van Tran, Raymond T Oji, Rebecca Rodriguez, Rebecca T Davis, Riley C Myers, PhD, Robert D Tollefsen, Ruben C Ayala, PharmD, Sandra S Saniga, Scott B Laufenberg, Scott N Lim, Serge L Beaucage, Sergio Chavez (NMI), Sheilyn H Huang, Shelley H Beausoleil, Sherri J Jackson, Sherri N Rohlf, MD, Sidney B Priesmeyer, Sripal R Mada, PhD, Stephanie A Slater, MS, Stuart W Russell, Sunitha K Rajaram, PhD, Susan D Yuscius, Susanne M Richardson, MS RAC, Suzanne M Healy, Tania Y Hall, Tawny L Colling, Teena H Aiken, Thomas W Nojek, Thuy T Nguyen, LCDR, Timothy C Grome, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Walden H Lee, William J Foust, William V Millar, Xiaohan Cai, PhD, Yi Wang, PhD, Young M Choi, PhD

Thea C Grome's Documents

Publish Date Document Type Title
June, 2020 EIR Myovant Sciences, Inc. - EIR, 2020-06-30
April, 2016 EIR Santa Clara Valley Medical Center IRB - EIR, 2016-04-11
January, 2019 EIR John Day - EIR, 2019-01-22
March, 2013 FDA 483 Hospira, Inc. US Service Center - Form 483, 2013-03-19
December, 2015 EIR Abbott Vascular - EIR, 2015-12-10
August, 2014 EIR Stellartech Research Corporation - EIR, 2014-08-14
January, 2017 FDA 483 Charles River Laboratories, Inc - Form 483, 2017-01-13
October, 2015 FDA 483 Center For Dermatology Clinical Research, Inc. - Form 483, 2015-10-07
June, 2017 EIR Ultragenyx Pharmaceutical Inc. - EIR, 2017-06-20
June, 2018 FDA 483 Soledad O. Lee, MD - Form 483, 2018-06-08
January, 2017 EIR Charles River Laboratories, Inc - EIR, 2017-01-13
June, 2017 FDA 483 Ultragenyx Pharmaceutical Inc. - Form 483, 2017-06-20
April, 2016 FDA 483 Santa Clara Valley Medical Center IRB - Form 483, 2016-04-11
June, 2013 EIR Bayer Healthcare, LLC - EIR, 2013-06-26
September, 2018 FDA 483 Linda Chao, PhD - Form 483, 2018-09-10
October, 2020 EIR Corcept Therapeutics Incorporated - EIR, 2020-10-19
January, 2016 FDA 483 Jazz Pharmaceuticals, Inc - Form 483, 2016-01-27
November, 2017 FDA 483 Rahul R. Aggarwal, MD - Form 483, 2017-11-21
September, 2014 FDA 483 Incumedx LLC - Form 483, 2014-09-12
April, 2015 FDA 483 Silk Road Medical Inc - Form 483, 2015-04-14
February, 2019 EIR Actelion Pharmaceuticals U.S., Inc. - EIR, 2019-02-28
May, 2019 EIR Endologix, Inc. - EIR, 2019-05-24
February, 2014 FDA 483 LumiQuick Diagnostics Inc. - Form 483, 2014-02-24
August, 2018 FDA 483 Oeyama-Moto Medical Foundation - Form 483, 2018-08-09
July, 2015 EIR 9 ayer Healthcare LLC - EIR, 2015-06-30
May, 2019 FDA 483 Endologix, Inc. - Form 483, 2019-05-24

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