FDA Investigator Marijo B Kambere, PhD

Marijo B Kambere, PhD has conducted inspections on 124 sites in 6 countries as of 16 Nov 2021. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
124
Last Inspection Date:
16 Nov 2021
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, China, India, United Kingdom of Great Britain and Northern Ireland, Portugal, Czechia
FDA Investigators that have inspected at least one site in common with Marijo B Kambere, PhD:
Abby M Miller, Ademola O Daramola, Alan D Grupe, Alanna L Mussawwir 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, Bryan L Maguckin, Bryan L Mcguckin, 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, Clint R Van Blaricom, Colleen F Hoyt, Connie P Rezendes, 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 Lboyd 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. Koffi A Amegadje, 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, Huiquan Wu, Hung H Do, MS, Ivis L Negron, 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 A Lopez, José E Meléndez, 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 Jproctor Jones, Ko U Min, Kristin M Abaonza, Kshitij A Patkar, 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, Maria Pkelly Doggett, MBA, Marie B Buen 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 Yclark Stuart, Miguel A Martinez Perez, Mihaly S Ligmond, Mikel T Wright, Mra Davism, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nancy E Byerly, Nataniel Phillips Sylvain, PhD, Neal L Adams, Ngoc Lan T 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, Robert D Tollefsen, Robin P Mathew, Roger F Zabinski, S Lori Brown, PhD MPH, Saied A Asbagh, Samina S Khan, Sandra A Hughes, Sandra K Wangen, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Santiago Gallardo Johnson, Santos E Camara, 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, 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 T Hadman, Susan W Ting, Tawny L Colling, Temar Q Williams, Terri 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, Veronica L Bush, Vickie J Kanion, Vioela J Caze, Virgilio F Pacio, CSO, Wayne W Grundstrom, Wenzheng Wendy 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
November, 2014 FDA 483 Response John M. Pagel - Form 483R, 2014-11-21
June, 2019 FDA 483 Ningxia Qiyuan Pharmaceutical Co., Ltd. - Form 483, 2019-06-28
March, 2019 FDA 483 Wuxi Apptec Suzhou Co.,Ltd - Form 483, 2019-03-08
August, 2019 FDA 483 Yibin Lihao Bio-technical Co., Ltd. - Form 483, 2019-08-06
June, 2014 EIR Arifulla Khan MD - EIR, 2014-06-11
April, 2013 EIR Arifulla Khan MD - EIR, 2013-04-10
May, 2011 FDA 483 Response East West Tea Company, LLC - Form 483R, 2011-06-01
October, 2021 FDA 483 Zhehai Wang - Form 483, 2021-10-21
April, 2019 FDA 483 Hisun Pharmaceutical (Hangzhou) Co., Ltd. - Form 483, 2019-04-10
September, 2015 FDA 483 Lonza Bend Inc. - Form 483, 2015-09-17
April, 2018 FDA 483 Response Avella of Deer Valley dba Avella Specialty Pharmacy - Form 483R, 2018-05-10
November, 2014 FDA 483 John M. Pagel - Form 483, 2014-12-01
November, 2014 EIR John M. Pagel - EIR, 2014-11-06
November, 2012 EIR David E. Dong - EIR, 2012-11-20
October, 2012 FDA 483 McKesson Corporation - Form 483, 2012-10-01
April, 2013 FDA 483 Arifulla Khan MD - Form 483, 2013-04-10
September, 2021 FDA 483 Jian Fang - Form 483, 2021-09-22
June, 2015 FDA 483 ION EXCHANGE (INDIA) LIMITED - Form 483, 2015-06-26
December, 2018 FDA 483 Enantiotech Corporation Limited - Form 483, 2018-12-07
September, 2016 FDA 483 Jubilant HollisterStier LLC - Form 483, 2016-09-30
June, 2012 FDA 483 Salem Hospital IRB - Form 483, 2012-06-25
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
July, 2015 EIR Jubilant HollisterStier LLC - EIR, 2015-07-31
March, 2019 FDA 483 Xinyu Pharmaceutical Co., Ltd. - Form 483, 2019-03-15
September, 2017 FDA 483 Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) - Form 483, 2017-09-20
September, 2015 FDA 483 Lonza Bend Inc. - Form 483, 2015-09-17
February, 2016 FDA 483 Option Care Enterprises, Inc. - Form 483, 2016-02-25
April, 2018 FDA 483 Avella of Deer Valley dba Avella Specialty Pharmacy - Form 483, 2018-04-25
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
March, 2018 EIR Nelson Laboratories, LLC - EIR, 2018-03-30
March, 2017 EIR Chinese Peptide Co., Ltd. - EIR, 2017-03-03
July, 2015 FDA 483 Jubilant HollisterStier LLC - Form 483, 2015-07-31
July, 2017 FDA 483 Oxarc, LLC - Form 483, 2017-07-14
January, 2017 FDA 483 AMO (Hangzhou) Co., Ltd. - Form 483, 2017-01-13
January, 2021 FDA 483 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. - Form 483, 2021-01-14
March, 2017 FDA 483 Chinese Peptide Co., Ltd. - Form 483, 2017-03-03
May, 2011 FDA 483 East West Tea Company, LLC - Form 483, 2011-05-19
May, 2011 EIR East West Tea Company, LLC - EIR, 2011-05-19
January, 2017 FDA 483 Shandong Analysis and Test Center - Form 483, 2017-01-18
May, 2016 FDA 483 Chongqing Pharmaceutical Research Institute Co., Ltd. - Form 483, 2016-05-19
March, 2017 FDA 483 Shanghai Desano Chemical Pharmaceutical Co., Ltd. - Form 483, 2017-03-10
June, 2014 FDA 483 Arifulla Khan MD - Form 483, 2014-06-11
July, 2015 FDA 483 Response Jubilant HollisterStier LLC - Form 483R, 2015-08-26
June, 2013 FDA 483 EarthLab Holdings Inc - Form 483, 2013-06-21
November, 2020 FDA 483 Yichang Humanwell Oral Solid Dosage Plant - Form 483, 2020-11-16
January, 2019 FDA 483 Farmasino Pharmaceuticals (Anhui) Company Limited - Form 483, 2019-01-18
August, 2013 FDA 483 Kirkman Laboratories, Inc. - Form 483, 2013-08-06
February, 2015 EIR Barretts Minerals Inc. - EIR, 2015-02-13
May, 2019 FDA 483 Pharmaron - Form 483, 2019-05-24
June, 2016 FDA 483 ALP Pharm Beijing Co., Ltd - Form 483, 2016-06-01

Experience Redica Systems’ 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