FDA Investigator Yun Wu, PhD
Yun Wu, PhD has conducted inspections on 10 sites in 7 countries as of 09 Oct 2023. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
10
Last Inspection Date:
09 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Korea (Republic of),
United States of America,
Ireland,
China,
Australia,
Taiwan,
Singapore
FDA Investigators that have inspected at least one site in common with Yun Wu, PhD:
Adam R Cooke,
Alicia M Mozzachio,
Amanda L Fyles,
Amy Devlin, PhD,
Amy H Ruble,
Andrew J Barrowcliff,
Arulvathani P Arudchandran,
Ashutosh Rao, PhD,
Barbara M Frazier,
Billy M Battles,
Bo Chi, PhD,
Bonita S Chester,
Bryan A Galvez,
Carl A Huffman, III,
Carlos M Gonzalez,
Cassandra L Abellard,
CDR Thomas R Berry, PPh,
Charles Yuanchia Kuo, PhD,
Cherrie A Zachary,
Christian D Lynch (CDL),
Christopher Downey, PhD,
Christopher R Czajka,
Claire M Minden,
Cynthia Jim, CSO,
Davinna Ligons, PhD,
Deborah Schmiel, PhD,
Dennis Cantellops Paite,
Devaughn Edwards,
Diane L Raccasi,
Dogbeda F Mackenzie,
Donald C Obenhuber, PhD,
Dr. Jun Liu, PhD,
Dr. Ralph M Bernstein, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Erin C Hill,
Erin D Mccaffery,
Erin Hill (EH),
Frances Namuswe, PhD,
Francis A Guidry,
Gabriel R Mclemore,
Gideon N Esuzor,
Hector A Carrero,
Hyung Yul Lee,
Ian L Mcwilliams,
Jacek Cieslak, PhD,
Jacqueline Mdiaz Albertini,
Jared P Stevens,
Jason F Chancey,
Javier E Santos,
Jawaid Hamid,
Jee Chung, PhD,
Jeffrey P Raimondi,
Jennifer D Hollstrom,
Jing Fang,
Joseph F Owens,
Junho Pak,
Kathleen D Culver,
Kristen Nickens, PhD,
Kshitij A Patkar,
Lakshmi Narasimhan, PhD,
Larry K Hampton,
Laura Fontan, MS,
Laurel A Beer,
Lawrence Carter, III,
Leiyun Boone, PhD,
Leopold Kong, PhD,
Leslie Arivera Rosado, PhD,
Lindsey Brown, PhD,
Lucila B Nwatu,
Madushini Dharmasena, PhD,
Maria Cecilia Tami, PhD,
Maria Gutierrez Hoffman, PhD,
Maria Gutierrez Lugo, PhD,
Maria Joselopez Barragan, PhD,
Marie F Morin,
Marion Michaelis,
Mary Kaulee,
Matthew B Casale,
Melanie M Walker,
Michael Shanks, MS,
Michele L Forster, PhD,
Michelle Yclark Stuart,
Milos Dokmanovic, PhD,
Monica Cburgos Garcia,
Monica Markovski, PhD,
Mra Davism,
Omotunde O Osunsanmi,
Patricia F Hughes, PhD,
Patrick J Lynch,
Paula A Trost,
Penny H Mccarver,
Perry H Gambrell,
Phillip Angart, PhD,
Prabhu P Raju,
Randy L Clarida,
Reyes Candau Chacon, PhD,
Rhonda Alexander,
Richard Ledwidge (nmi), PhD,
Riley C Myers, PhD,
Robert C Coleman,
Rose Ashley,
Sarah Arden,
Sarah Kennett, PhD,
Saundrea A Munroe,
Seneca D Toms,
Shafiq S Ahadi,
Shirley J Berryman,
Simon Williams, PhD,
Sonya M Edmonds,
Steven Fong, MS, PhD,
Tamika D Cathey,
Tammara A Stephens,
Thomas R Withers,
Thuy T Nguyen, LCDR,
Veronica Fuentes, MS,
Vicky C Stoakes,
Virginia Carroll, PhD,
Viviana Matta,
Wayne E Seifert,
Xiaoxiao Pan, PhD,
Xu Michael Di, PhD,
Xuhong Li,
Yi Wang, PhD,
Yuan Chia Kuo,
Zhenzhen Liu, PhD,
Zhong Li, PhD
Yun Wu, PhD's Documents
Publish Date | Document Type | Title |
---|---|---|
April, 2021 | FDA 483 Response | FUJIFILM Diosynth Biotechnologies U.S.A., Inc - Form 483R, 2021-05-12 |
August, 2020 | FDA 483 | Patheon Manufacturing Services LLC - Form 483, 2020-08-14 |
August, 2020 | FDA 483 Response | Patheon Manufacturing Services LLC - Form 483R, 2020-09-03 |
June, 2022 | FDA 483 | EirGenix Inc - Form 483, 2022-06-16 |
April, 2021 | EIR | FUJIFILM Diosynth Biotechnologies U.S.A., Inc - EIR, 2021-04-21 |
May, 2022 | FDA 483 | Tanvex BioPharma USA, Inc - Form 483, 2022-05-04 |
August, 2020 | EIR | Patheon Manufacturing Services LLC - EIR, 2020-08-14 |
April, 2021 | FDA 483 | FUJIFILM Diosynth Biotechnologies U.S.A., Inc - Form 483, 2021-04-21 |
August, 2021 | FDA 483 | Samsung Biologics Co., Ltd. - Form 483, 2021-08-24 |
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