FDA Investigator Makini Cobourne Duval, PhD
Makini Cobourne Duval, PhD has conducted inspections on 22 sites in 8 countries as of 04 Dec 2023. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
22
Last Inspection Date:
04 Dec 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
India,
New Zealand,
United States of America,
Israel,
Turkey,
Jordan,
Canada,
Spain
FDA Investigators that have inspected at least one site in common with Makini Cobourne Duval, PhD:
Alan P Kurtzberg,
Alanna L Mussawwir Bias,
Alicia M Mozzachio,
Amanda E Lewin, PhD,
Anastasia M Shields,
Anders W Evenson,
Andrea A Branche,
Andrew Le,
Anita Narula, PhD,
Anita R Michael,
Anthony E Keller, RPh,
Atul J Agrawal,
Azza Talaat,
Barbara A Rusin,
Barbara Janine Breithaupt,
Bonita S Chester,
Brandon C Heitmeier,
Camille D Brown,
Chaoying C Ma,
Charles D Brown,
Charles R Cote, RIC,
Christopher D Leach,
Clotia Cabbey Mensah,
Courtney N Long,
Craig A Garmendia,
Cynthia M Goudeau,
Daniel J Lahar,
Daniel L Aisen,
Debra I Love,
Denise L Burosh,
Dipesh K Shah,
Dr. Carmelo Rosa,
Dr. Gopa Biswas, PhD,
Dr. Mark J Seaton, PhD,
Eileen A Liu,
Emest F Bizjak,
Emily J Orban,
Eric M Mueller, PharmD,
Eric S Pittman,
Feiyan Jin,
Gajendiran Mahadevan, PhD,
Gale L Glinecki,
Gavin T Cua,
Gene D Arcy,
Gene R Gunn,
Gulshan R Anand,
Gwyn G Dickinson,
Hasan A Irier, PhD,
Himanshu Gupta, PhD,
Hyojong Kwon, PhD,
Ivis L Negron,
Jacob G Lutz,
Jacob W Reynolds,
Jacqueline Mdiaz Albertini,
Jagan Mohanr Parepally, PhD,
James C Maclaughlin,
James M Mason,
James S Cartwright,
Jane M Kreis,
Janete F Guardia,
Jared P Stevens,
Jasjeet K Sekhon,
Jay V Jariwala,
Jeanne J Thai,
Jeffery A Hangartner,
Jeffrey A Sommers,
Jennifer C Adams,
Joanne M Schlossin,
John A Iwen,
Jonathan R Campos,
Jose A Lopez,
Jose Acruz Gonzalez,
José E Meléndez,
Jose Ohernandez Guzman,
Joseph L Despins, PhD,
Joy P Matthias,
Junho Pak,
Justin A Boyd,
Kara A Scheibner, PhD,
Kari M Johansen,
Katherine Szestypalow,
Kellia N Hicks,
Kenneth H Williams,
Kham Phommachanh,
Kip J Hanks,
Larry K Austin,
Lata C Mathew, PhD,
Li Hongpaul Yeh, PhD,
Liming Zhang,
Linda F Murphy,
Linda R Kuchenthal,
Lori A Gioia,
Lori J Silverstein,
Luis A Dasta,
Maan S Abduldayem,
Margaret M Annes,
Maria V Price,
Massoud Motamed,
Matthew C Watson,
Mei Ou,
Meisha Waters,
Melkamu Getie Kebtie, PhD,
Michael A Charles,
Michael A Taylor,
Michael G Sinkevich,
Michael P Anthony,
Michael Serrano,
Minh D Phan,
Mohsen Rajabi Abhari, FDA,
Muralidhara B Gavini, PhD,
Nancy A Bellamy,
Neal D Singletary, PhD,
Nicholas A Violand,
Nicholas Z Lu,
Nicola M Fenty Stewart,
Nikki S Ramirez,
Pankaj H Amin,
Parul M Patel,
Patrick C Klotzbuecher,
Patty P Kaewussdangkul,
Paul A Bonneau,
Paul L Bellamy,
Peter E Baker,
Peter R Lenahan,
Raymond T Oji,
Richard W Berning,
Rita K Kabaso,
Robert J Doyle,
Robert J Martin,
Robert M Barbosa,
Ronda Rloyd Jones,
Ruben C Ayala, PharmD,
Saleem A Akhtar,
Sam H Haidar, PhD,
Samuel H Chan, PharmD,
Sandra A Hughes,
Sarah E Rhoades,
Sarmistha Sanyal, PhD,
Scott B Laufenberg,
Scott T Ballard,
Seneca D Toms,
Seongeun Cho (Julia), PhD,
Sheri L Stephenson,
Shirley H Isbill,
Sripal R Mada, PhD,
Stanley Au,
Stephen D Brown,
Steven A Gonzales,
Susan M Jackson,
Susanna E Ford,
Susanne M Richardson, MS RAC,
Tamil Arasu, PhD,
Tawny L Colling,
Thomas J Arista,
Thomas W Gordon,
Walden H Lee,
Xiaokuang Lai, PhD,
Xikui Chen (nmi), PhD,
Yiyue Zhang (nmi), PhD,
Young M Choi, PhD,
Yvins Dezan,
Zachary A Bogorad,
Zhaoyang Meng
Makini Cobourne Duval, PhD's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| March, 2017 | EIR | PPD Development, L.P. - EIR, 2017-03-03 |
| March, 2017 | FDA 483 | PPD Development, L.P. - Form 483, 2017-03-03 |
| June, 2017 | FDA 483 | Pharmaron (Exton) Lab Services LLC - Form 483, 2017-06-09 |
| January, 2018 | FDA 483 | SYNGENE INTERNATIONAL LIMITED - Form 483, 2018-01-26 |
| November, 2017 | FDA 483 | Sun Pharmaceutical Medicare Limited - Form 483, 2017-11-17 |
| January, 2018 | FDA 483 | Panexcell Clinical Lab PVT. LTD. - Form 483, 2018-01-19 |
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.
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