FDA Investigator Marijo B Kambere, PhD

Marijo B Kambere, PhD has inspections in 6 countries as of 08 Sep 2023. Marijo B Kambere, PhD has collaborated with a combinined 5170 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
124
Last Inspection Date:
08 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
China, United States of America, United Kingdom of Great Britain and Northern Ireland, India, Czechia, Portugal
Co-Investigator(s):
Abby M Miller, Ademola O Daramola, Alan D Grupe, Alanna Lmussawwir Bias, Alexander M Kay, Alice S Tsao, Amanda L Fyles, Andrew K Haack, PhD, Andrew Le, Anh Trinh T Nguyen, Anissa M Vargas, Anita Narula, PhD, Annette L Diggs, Arsen Karapetyan, Ashar P Parikh, Astrida B Mattson, Avery J Dennis, Babatunde D Babalola, Barbara Janine Breithaupt, Betsy C Galliher, Bradley Dworak, PhD, Brenda K Alford, Brenda L Reihing, Brenda W Uratani, PhD, Brian J Ryan, Bryan A Galvez, Byungja E Marciante, Camerson E Moore, Carl A Anderson, Carl A Huffman, III, Carl Lee, Carrie A Hughes, Caryn M Mcnab, Celia L Hutchinstein, Charles I Ann, Charles M Edwards, Charles R Bonapace, PhD, Cheryl A Clausen, Chiang Syin, PhD, Chiaochun J Wang, Christian D Lynch (CDL), Christine A Harman, PhD, Christopher R Czajka, Christopher S Genther, Christopher T Middendorf, Clinton R Vanblaricom, Connie P Rezendes, Connie P Rezenes, Courtney R Ingalsbe, Crystal A Harlan, Crystal Monroy, Cynthia J Lee, MS, Dandan Wang, PhD, Daniel A Congdon, Daniel J Lahar, Darren S Brown, David Acevedo, David H Smith, David J Daworski, David J Gomes, Dawn E Barkans, Deborah L Wade, Debra L Boyd Seale, Devon M Shoop, Diane T Wade, MS, Dolores E Price, Don A Brunssen, Don H Bark, PhD, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Mark J Seaton, PhD, Dr. Robert C Horan, MD, Dr. Zhou Chen (nmi), MD PhD, Edmund F Mrak, Jr, Edwin Martinez, Edwin Melendez, Eileen A Liu, Elizabeth S Howell, Eric L Dong, BS, Eric M Mueller, PharmD, Erika V Butler, Farhana Khan, Felix J Marrero, Felix Maldonado, Francis J Eng, George Lunn, PhD, Gerard Pde Leon, Ginger M Sykes, Gloria J Baca, MS, Grace E Mcnally, Gregson A Joseph, Hanna L Potter, Heika R Bounds, Heika R Tait, Hugh A Grimoldby, Hugh Grimoldby, Huiquan Wu, Hung H Do, MS, Ivis Lnegron Torres, Jacqueline Mdiaz Albertini, James C Henry, James C Maclaughlin, James R Montero, James S Cartwright, James S Stuart, BS, Jamie L Dion, Jane M Kreis, Janete F Guardia, Jean C Colon Lopez, Jean R Mccurry, Jeanne M Weishaar, Jeffery A Hangartner, Jeffrey J Leclair, Jeffrey N Gerdes, Jen Sui, Jennifer L Bridgewater, Jessie E Morris, Jinkee Mvila Binayug, Joanne M Schlossin, Joel D Hustedt, Joey V Quitania, Jogy George, John W Banks, Jonathan R Ormond, Jonathan T Little, Jose Alopez Rubet, Jose E Melendez, DDC, Jose R Hernandez, Joseph M Hudak, Juan A Morales, Julia E Chervoni, Julian C Hanson, Julie A Stocklin, Justin A Boyd, Kari M Johansen, Katherine L Arnold, Katherine Szestypalow, Kathryn A Krentz, Keegan B Mixon, Kelsey A Hustedt, Kenneth O Gee, PhD, Kenneth S Boehnen, Kevin P Regan, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kimberley A Hoefen, Kimberly J Proctor Jones, Ko U Min, Kristin M Abaonza, Kumar G Janoria, Larry K Austin, Laurel A Beer, Laurimer Kuilan Torres, Lawrence Y Lee, PhD, LCDR Debra Emerson, Lewis K Antwi, Leya A Grosch, Liming Zhang, Linda S Leja, Lindsey M Schwierjohann, Lisa A Bowden, Lisa K Capron, Lori J Silverstein, Luis A Dasta, Lynda L Perry, PhD, Marc A Jackson, Jr, Marcus A Ray, Margo C Jones, Margo Cl Jones, Maria Pkelly Doggett, MBA, Marie Bbuen Bigornia, Marie F Morin, Marion W Nadeau, Mariza M Jafary, Mark E Imsland, Mark W Babbitt, Marquessa M Rowe, Mary E Storch, Matthew B Casale, Matthew R Dionne, Maxine H Wong, Meisha R Sampson, Meisha Waters, Michael A Charles, Michael J Kuchta, Michael L Chasey, Michael R Goga, Michelle Y Clark Stuart, Miguel A Martinez, Mihaly S Ligmond, Mikel T Wright, Mra Davism, Muralidhara B Gavini, PhD, Nancy E Byerly, Nataniel Phillips Sylvain, PhD, Neal L Adams, Ngoc Lant Nguyen, Nicholas L Hunt, Niraj R Mehta, PhD, Omotunde O Osunsanmi, Patty P Kaewussdangkul, Paul M Kawamoto, Paula A Trost, Paula J Wilkerson, Peter C Chow, Peter E Baker, Prabhu P Raju, Pratik S Upadhyay, DDC, Rachelle M Deskins, Randy L Self, Rebecca Rodriguez, Ricki A Chase, Ricki Achase Off, Robert D Tollefsen, Roger F Zabinski, S Lori Brown, PhD MPH, Saied A Asbagh, Samina S Khan, Sandra A Hughes, Sandra K Wangen, Sangeeta M Khurama, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Santiago Gallardo Johnson, Santos E Camara, Savini, Scott T Ballard, Scott W Fox, Seneca D Toms, Sharon I Gundersen, Sharon K Thoma, PharmD, Shelagh D Schopen, Sherri N Rohlf, MD, Shuen G Chai, Sixto M Mercado Rios, Sonia R Peterson, Sony Mathews, Sridhar Thumma, Stanley B Eugene, BS, BME, State Agency, Stephanie A Jameson, Stephanie A Slater, MS, Stephen J Kilker, Stephen J Mottola, Steven C Madzo, Steven D Kehoe, Steven R Ziser, Sumit Sen, Sunitha K Rajaram, PhD, Sunny R Muir, Susan F Laska, MS, Susan M Jackson, Susan W Ting, Susant Hadman, Tawny L Colling, Temar Q Williams, Terri L Dodds, Terry L Dodds, Theresa Kirkham (NMI), Theressa B Smith, Thomas C Mclean, CFS, Thomas J Arista, Timothy D Evans, Timothy H Vo, Tina S Roecklein, Toyin B Oladimeji, Tracy K Li, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Vanessa Y Gelsey, PhD, Vickie J Kanion, Vioela J Caze, Virgilio F Pacio, CSO, Wayne W Grundstrom, Wenzheng Zhang, William F Lagud, Jr, Xiaojun Yan, Xiaoping Guan, Xing Wang, PhD, Xiomara Copeland, Young M Yoon, Zachary A Bogorad, Zachary L Stamm, Zhigang Sun, PhD, Zi Qiang Gu

Marijo B Kambere, PhD's Documents

Publish Date Document Type Title
July, 2017 FDA 483 Oxarc, LLC - Form 483, 2017-07-14
July, 2015 FDA 483 Response Jubilant HollisterStier LLC - Form 483R, 2015-08-26
June, 2013 FDA 483 EarthLab Inc - Form 483, 2013-06-21
November, 2020 FDA 483 Yichang Humanwell Oral Solid Dosage Plant - Form 483, 2020-11-16
April, 2019 FDA 483 Hisun Pharmaceutical (Hangzhou) Co., Ltd. - Form 483, 2019-04-10
January, 2017 FDA 483 Shandong Analysis and Test Center - Form 483, 2017-01-18
June, 2012 EIR Salem Hospital IRB - EIR, 2012-06-25
April, 2018 EIR Avella of Deer Valley dba Avella Specialty Pharmacy - EIR, 2018-04-19
May, 2016 FDA 483 Chongqing Pharmaceutical Research Institute Co., Ltd. - Form 483, 2016-05-19
June, 2015 FDA 483 ION EXCHANGE INDIA LIMITED - Form 483, 2015-06-26
November, 2012 EIR David E. Dong - EIR, 2012-11-20
June, 2012 FDA 483 Salem Hospital IRB - Form 483, 2012-06-25
November, 2014 FDA 483 John M. Pagel - Form 483, 2014-12-01
November, 2014 EIR John M. Pagel - EIR, 2014-11-06
September, 2015 FDA 483 Bend Research Inc. - Form 483, 2015-09-17
June, 2014 EIR Arifulla Khan MD - EIR, 2014-06-11
April, 2013 EIR Arifulla Khan MD - EIR, 2013-04-10
April, 2013 FDA 483 Arifulla Khan MD - Form 483, 2013-04-10
April, 2018 FDA 483 Response Avella of Deer Valley dba Avella Specialty Pharmacy - Form 483R, 2018-05-10
January, 2021 FDA 483 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. - Form 483, 2021-01-14
October, 2012 FDA 483 McKesson Corporation - Form 483, 2012-10-01
May, 2011 FDA 483 Response East West Tea Company, LLC - Form 483R, 2011-06-01
September, 2017 FDA 483 Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) - Form 483, 2017-09-20
September, 2016 FDA 483 Jubilant HollisterStier LLC - Form 483, 2016-09-30
February, 2016 FDA 483 Option Care Enterprises, Inc. - Form 483, 2016-02-25
June, 2019 FDA 483 Ningxia Qiyuan Pharmaceutical Co., Ltd. - Form 483, 2019-06-28
July, 2015 FDA 483 Jubilant HollisterStier LLC - Form 483, 2015-07-31
January, 2019 FDA 483 Farmasino Pharmaceuticals (Anhui) Company Limited - Form 483, 2019-01-18
October, 2018 FDA 483 Dongying Tiandong Pharmaceutical Co.,Ltd - Form 483, 2018-10-19
December, 2019 FDA 483 Tianjin Asymchem Pharmaceuticals Co., Ltd. - Form 483, 2019-12-06
March, 2017 FDA 483 Chinese Peptide Co., Ltd. - Form 483, 2017-03-03
March, 2017 EIR Chinese Peptide Co., Ltd. - EIR, 2017-03-03
January, 2017 FDA 483 AMO (Hangzhou) Co., Ltd. - Form 483, 2017-01-13
August, 2013 FDA 483 Kirkman Laboratories, Inc. - Form 483, 2013-08-06
June, 2014 FDA 483 Arifulla Khan MD - Form 483, 2014-06-11
October, 2021 FDA 483 Zhehai Wang - Form 483, 2021-10-21
September, 2015 FDA 483 Bend Research Inc. - Form 483, 2015-09-17
July, 2015 EIR Jubilant HollisterStier LLC - EIR, 2015-07-31
September, 2021 FDA 483 Jian Fang - Form 483, 2021-09-22
March, 2018 EIR Nelson Laboratories, LLC - EIR, 2018-03-30
May, 2019 FDA 483 Pharmaron - Form 483, 2019-05-24
April, 2018 FDA 483 Avella of Deer Valley dba Avella Specialty Pharmacy - Form 483, 2018-04-25
March, 2019 FDA 483 Xinyu Pharmaceutical Co., Ltd. - Form 483, 2019-03-15
December, 2018 FDA 483 Enantiotech Corporation Limited - Form 483, 2018-12-07
March, 2019 FDA 483 Wuxi Apptec Suzhou Co.,Ltd - Form 483, 2019-03-08
May, 2011 FDA 483 East West Tea Company, LLC - Form 483, 2011-05-19
August, 2019 FDA 483 Yibin Lihao Bio-technical Co., Ltd. - Form 483, 2019-08-06
May, 2011 EIR East West Tea Company, LLC - EIR, 2011-05-19
November, 2014 FDA 483 Response John M. Pagel - Form 483R, 2014-11-21
March, 2017 FDA 483 Shanghai Desano Chemical Pharmaceutical Co., Ltd - Form 483, 2017-03-10
February, 2015 EIR Barretts Minerals Inc. - EIR, 2015-02-13
June, 2016 FDA 483 ALP Pharm Beijing Co., Ltd - Form 483, 2016-06-01

Experience Redica System's NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more