FDA Investigator Marcellinus D Dordunoo

Marcellinus D Dordunoo has conducted inspections on 85 sites in 15 countries as of 25 Apr 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
85
Last Inspection Date:
25 Apr 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, China, India, Netherlands, Taiwan, Spain, Canada, France, United Kingdom of Great Britain and Northern Ireland, Norway, Japan, Costa Rica, Italy, Germany, Switzerland
FDA Investigators that have inspected at least one site in common with Marcellinus D Dordunoo:
Abdollah Koolivand, Alan P Kurtzberg, Alberto A Viciedo, Alice S Tsao, Alicia M Mozzachio, Alison N Stieg, Amy Chen, Amy M Codella, Amy M Cramer, Amy N Chen, Anastasia I Offordile, Anastasia M Shields, Andrea A Branche, Andrea J Schmidt, Andrew O Ejiofor, Angela E Glenn, Anita R Michael, Ankur C Patel, Annemarie Bodnar, Anthony W Hite, Ashar P Parikh, Atul J Agrawal, Azza Talaat, Barbara A Gullick, Barbara J Maulfair, Barbara J Rincon, Barbara Jwilimczyk Macri, Bijoy Panicker, Brian J Ryan, Brian P Putz, Brooke K Higgins, Brooke K Seeman, Bryan L Mcguckin, Carla J Lundi, Carole L Jones, Carrie A Hughes, Cary Greene, Caryn M Mcnab, Cathleen A Carr Sharpe, CDR Jeremy L Wally, PhD, CDR Rochelle B Young, RPh, MSA, Chaltu Nwakijra, Charanjeet Jassal, Charles M Edwards, Cheryl D Mccall, Chiang Syin, PhD, Christina K Theodorou, Christina M Picard, Christopher S Keating, Christopher T Middendorf, Claude Noel Y Zanetsie, Cody D Rickman, Colleen F Hoyt, Craig D Zagata, Cynthia A Palmer, Dale A Nyberg, Daniel J Deciero, Daniel J Grabicki, Daniel J Lahar, Daniel J Min, Daniel J Roberts, Darren S Brown, David A Oluwo, David J Gomes, David M Beltran, David Y Hernandez, Davis, Dawn L Wydner, Deborah J Parris, Debra J Fracassa, Denise M Digiulio, Desiree C Iya, Deyaa Shaheen, Dhaval H Patel, Diane T Bargo, Diane T O'brien, Dipesh K Shah, Doan T Nguyen, PharmD, Don H Bark, PhD, Donald H Barks, Donald L Lech, Douglas A Campbell, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Dominick Roselle, Dr. Robert C Horan, MD, Dr. Roslyn F Powers, Dr. Yubing Tang, Edmund F Mrak, Jr, Edward E Lockwood (EEL), Edward O'shaughnessy, Edwin Melendez, Elaine E Gilfillan, Elaine Gilfillan, Emest F Bizjak, Emilie E Kahn, Emmanuel Jramos Maldonado, Eric L Dong, BS, Eric M Mueller, PharmD, Eric Rothschild, Erika E Englund, PhD, Erika V Butler, Erin D Mccaffery, Erin L Nagel, Farhana Khan, Felix Maldonado, Frank J Marciniak, Frederick F Razzaghi, Gabriel Craig, Gajendiran Mahadevan, PhD, Gavin T Cua, Gayle S Lawson, George J Flynn, George Pyramides, Gerard Pde Leon, Gregson A Joseph, Guerlain Ulysse, Guo Q Shen, Hala L Selby, Harry J Brewer, Hector Jcolon Torres, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Hung H Do, MS, Ivan E Reyes, Jacob W Reynolds, Jai P Singh, James A Lane, James D Bridges, James I Giefer, James M Mason, James M Simpson, James W Leonette, Janet A Rajan, Javier O Vega, Jazmine N Brown, Jeanne D Shaffer, Jeffery A Hangartner, Jeffrey P Raimondi, Jennifer L Huntington, Jennifer M Gogley, Jessica L Pressley, Jessica M Monteiro, Jessica S Estriplet, Joanne E King, Jocelyn E Massey, Joel D Hustedt, Jogy George, John A Podsadowski, John Dan, Johnna L Bleem, Jonah S Ufferfilge, Jonathan W Chapman, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose R Hernandez, Joseph J Vannelli, Joseph R Lambert, Joseph W Matthews, Juanita P Versace, Judy C Nepsa, Junho Pak, Justin A Boyd, Justine Tomasso, Ka L Wong, Kaitlyn R Kornberg, Karen E D'orazio, Karen L Kosar, Katherine Szestypalow, Kathleen B Swat, Kathleen E Mcafoose, Kathleen M Jordan, Kathy E Craven, Kathy E Noe, Keith M Reilly, Kejun Cheng, Kelli F Dobilas, Kellia N Hicks, Kelvin Cheung, Kendra L Brooks, Kenneth M Gordon, Kenneth Nieves, Kevin A Gonzalez, Kevin D Kallander, Kham Phommachanh, Kim M Downing, Kimberly M Lichter, Ko U Min, Kristina L Conroy, Kristy A Zielny, Kyle D Covill, Laishan L Lam, Larry K Austin, Lata C Mathew, PhD, Laura A Munsterman, Laurissa S Flowers, Lawrence Harmon, Jr, Lawrence J Stringer, Lawrence R Johnson, LCDR Anastasia M Piliafas Brown, LCDR Debra Emerson, LCDR Margaret Edi Gennaro, LCDR Matthew J Morrison, Leon L Law, Li Li, Liatte Kreuger, PharmD, Liming Zhang, Linda F Murphy, Linda M Sacco, Lindsey M Schwierjohann, Lisa L Flores, Lisa R Hilliar, Loretta Nemchik, Lori S Lawless, LT John M Mastalski, Lucas B Leake, Luella J Rossi, Luis A Dasta, Luis Mburgos Medero, Mamta Gautam Basak, PhD, Marc S Neubauer, Marcus A Ray, Marcus F Yambot, Margaret Faulkner, Margaret M Annes, Margaret M Doherty, Margaret M Sands, Maria A Reed, Marie B Buen Bigornia, Marvin D Jones, Massoud Motamed, Matt D Suedkamp, Matthew B Casale, Matthew D Schnittker, Matthew M Henciak, Matthew R Noonan, Melanie W Pishnery, Melissa J Garcia, Melissa T Roy, Meredith L Sheridan, Merideth K Rose, Michael A Charles, Michael A Taylor, Michael E Maselli, Michael L Casner, Michael O Idowu, Michael R Goga, Michael R Klapal, Michael Serrano, Michael Shanks, MS, Michael W Burd, Michele Perry Williams, Mindy M Chou, Monika Borkowska, Mra B Kamberem, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Natasha Gupta, Nebil A Oumer, Neil J Bonzagni, PhD MPH, Nerizza B Guerin, Nibin Varghese, MS, Nicholas A Violand, Nicole A Lloyd, Nicole E Knowlton, Niketa Patel, Nina D Patel, Parul M Patel, Patricia A Morrow, Patricia H Dlugosz, Patrick C Klotzbuecher, Patrick L Wisor, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Penny H Mccarver, Peter E Baker, Peter R Lenahan, Phal K Chhun, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Puspa Suresh Jayasekara, Qin Xu, Rachael O Oyewole, Rachel C Harrington, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Raquel Gonzalez Rivera, Rebecca Rodriguez, Regina T Brown, Richard D Manney, Richard E Needham, Richmond K Yip, Rita K Kabaso, Robert C Steyert, Robert D Tollefsen, Robert H Wittorf, Robert J Martin, Robert M Barbosa, Rose Ljean Mary, Roseline N Boateng, Roy R Rinc, Rumany C Penn, PharmD, Russell J Glapion, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Sam Pepe, Samantha J Bradley, Samina S Khan, Sandra A Hughes, Sangeeta M Khurana, PhD, Santos E Camara, Sarah A Hassas, Satheesh Thomas, Saundrea A Munroe, Schultz, Scott T Ballard, Sena G Dissmeyer, Sharon K Thoma, PharmD, Shirley J Berryman, Shirshendu K Deb, PhD, Shusheen A Alexander, Simone E Pitts, Sixto M Mercado Rios, Sony Mathews, Sparky L Bartee, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen D Brown, Stephen D Eich, Stephen J Mottola, Stephen R Souza, Steven C Madzo, Steven J Thurber, Steven P Donald, Susan D Yuscius, Susan F Laska, MS, Susan W Ting, Susanna E Ford, Suzanne M Healy, Suzanne M Muchene, Taichun Qin, PhD, Tajah L Blackburn, Tamil Arasu, PhD, Tara G Bizjak, Tara R Gooen, Tawny L Colling, Tekalign Wondimu, Teresa I Navas, Theresa Kirkham (NMI), Thomas E Friel, Thomas J Arista, Tiffani D Wilson, Timothy T Kapsala, Tina M Pawlowski, Tomika L Bivens, Tonia F Bernard, Torrance J Slayton, Toyin B Oladimeji, Tracey L Harris, Truong Xuan Nguyen (Andy), Tsedenia Woldehanna, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie C Reed, Vipulchandra N Dholakia, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Viviana Matta, Vivin George, Vlada Matusovsky, Walden H Lee, Walter L Fava, Wanda Y Honeyblue, Wayne E Seifert, Wayne J Meyer, Wen Ning Chan (Sally), Wendy G Tan, PhD, William J Leonard, William V Millar, Xiaokuang Lai, PhD, Yasamin Ameri, Yifan Wang, Yiyue Zhang (nmi), PhD, Yumi J Hiramine, Yvesna C Blaise, Yvins Dezan, Zachary L Miller, Zachary L Stamm, Zakaria I Ganiyu, Zhaoyang Meng, Zhongren Wu

Marcellinus D Dordunoo's Documents

Publish Date Document Type Title
September, 2021 FDA 483 Pharmaceutics International, Inc. - Form 483, 2021-09-29
December, 2021 FDA 483 Sigmapharm Laboratories, LLC - Form 483, 2021-12-07
August, 2019 FDA 483 Response Fresenius Kabi USA, LLC - Form 483R, 2019-10-21
December, 2017 FDA 483 Otsuka Chemical Co., Ltd - Form 483, 2017-12-01
August, 2017 FDA 483 Suco Inc - Form 483, 2017-08-02
September, 2021 EIR Pharmaceutics International, Inc. - EIR, 2021-09-29
March, 2017 FDA 483 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical - Form 483, 2017-03-23
December, 2017 FDA 483 Sumitomo Chemical Company, Limited - Form 483, 2017-12-08
June, 2019 FDA 483 NATCO PHARMA LIMITED - Form 483, 2019-06-05
March, 2018 EIR MSN Laboratories Private Limited - EIR, 2018-03-09
January, 2020 FDA 483 LUPIN LIMITED - Form 483, 2020-01-10
August, 2016 FDA 483 Garonit Pharmaceutical, Inc. - Form 483, 2016-08-26
April, 2020 FDA 483 Emergent Manufacturing Operations Baltimore LLC - Form 483, 2020-04-20
September, 2021 EIR Pharmaceutics International, Inc. - EIR, 2021-09-29
December, 2017 FDA 483 TAYCA CORPORATION - Form 483, 2017-12-15
December, 2022 FDA 483 ABRYL LABORATORIES PRIVATE LIMITED - Form 483, 2022-12-06
August, 2022 EIR New Dawn Manufacturing - EIR, 2022-08-29
May, 2022 FDA 483 Safe Chain Solutions, Llc - Form 483, 2022-05-10
May, 2022 FDA 483 Response Safe Chain Solutions, Llc - Form 483R, 2022-05-10
December, 2018 EIR Chirogate International Inc. - EIR, 2018-12-06
November, 2019 FDA 483 Apex Pharmacy, LLC - Form 483, 2019-11-07
June, 2021 FDA 483 Bell-More Labs Inc - Form 483, 2021-06-07
September, 2021 FDA 483 Pharmaceutics International, Inc. - Form 483, 2021-09-29
February, 2024 FDA 483 EUGIA SEZ PRIVATE LIMITED - Form 483, 2024-02-29
January, 2020 FDA 483 BIOCON LIMITED - Form 483, 2020-01-24
November, 2021 EIR Ampac Fine Chemicals Virginia, LLC - EIR, 2021-11-09
March, 2023 FDA 483 TERUMO CORPORATION - Form 483, 2023-03-21
March, 2018 FDA 483 Dr Reddy's Laboratories Limited - Form 483, 2018-03-16
November, 2022 FDA 483 ChiRhoClin, Inc - Form 483, 2022-11-03
August, 2019 EIR Fresenius Kabi USA, LLC - EIR, 2019-08-12
April, 2020 EIR Emergent Manufacturing Operations Baltimore LLC - EIR, 2020-04-20
August, 2019 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2019-08-12
April, 2020 EIR Emergent Manufacturing Operations Baltimore LLC - EIR, 2021-04-20
May, 2019 FDA 483 Intas Pharmaceuticals Limited - Form 483, 2019-05-28
June, 2022 FDA 483 Glenmark Pharmaceuticals Limited - Form 483, 2022-06-22
September, 2021 FDA 483 Response Pharmaceutics International, Inc. - Form 483R, 2021-11-18
August, 2022 FDA 483 Frontage Laboratories, Inc. - Form 483, 2022-08-11
March, 2023 FDA 483 TERUMO YAMAGUCHI CORPORATION - Form 483, 2023-03-30
August, 2018 FDA 483 HV Pharmacy dba Hunt Valley Pharmacy - Form 483, 2018-08-17
December, 2022 FDA 483 Alembic Pharmaceuticals Limited - Form 483, 2022-12-16
December, 2023 FDA 483 Xiamen Tiger Medical Company, Ltd - Form 483, 2023-12-19
September, 2022 FDA 483 Lilly France - Form 483, 2022-09-29
June, 2018 FDA 483 Megafine Pharma (P) Limited - Form 483, 2018-06-15
March, 2018 FDA 483 DOCTORS ORGANIC CHEMICALS DIVISION - Form 483, 2018-03-02
March, 2019 FDA 483 Henan Kangdi Medical Devices Co. Ltd. - Form 483, 2019-03-07
February, 2023 FDA 483 SriSai Biopharmaceutical Solutions, LLC - Form 483, 2023-02-23
April, 2020 FDA 483 Response Emergent Manufacturing Operations Baltimore LLC - Form 483R, 2020-05-08
February, 2019 FDA 483 Qilu Pharmaceutical Co., Ltd. - Form 483, 2019-02-22
March, 2018 FDA 483 MSN Laboratories Private Limited - Form 483, 2018-03-09
July, 2022 FDA 483 CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED - Form 483, 2022-07-01
November, 2017 EIR Quality Packaging Specialists International, LLC - EIR, 2017-11-03
June, 2016 FDA 483 Nutra-Med Packaging - Form 483, 2016-06-29
December, 2018 FDA 483 Vida International, Inc. - Form 483, 2018-12-13
September, 2017 EIR DSM Nutritional Products (UK) Ltd. - EIR, 2019-03-28

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