FDA Investigator Leiyun Boone, PhD
Leiyun Boone, PhD has conducted inspections on 5 sites in 3 countries as of 10 Jul 2023. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
5
Last Inspection Date:
10 Jul 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
United States of America,
Germany,
Taiwan
FDA Investigators that have inspected at least one site in common with Leiyun Boone, PhD:
Aditi S Thakur,
Alberto A Viciedo,
Alice C Silva,
Amy C Jordan,
Amy N Chen,
Arie C Menachem,
Calvin B Koerner,
Caryn M Mcnab,
CDR Rochelle B Young, RPh, MSA,
Charles Yuanchia Kuo, PhD,
Daryl A Dewoskin,
Dawn L Wydner,
Diane L Raccasi,
Dien N Nguyen,
Djamila Harouaka,
Donald C Obenhuber, PhD,
Douglas A Campbell,
Dr. Ralph M Bernstein, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Edmund F Mrak, Jr,
Guerlain Ulysse,
Helen B Ricalde,
Jacek Cieslak, PhD,
Janet L Bowen,
Jennifer M Gogley,
Jie He,
José E Meléndez,
Jose M Melendez,
Jose Ohernandez Guzman,
Julie D Bringger,
Justin A Boyd,
Karen A Briggs,
Kathleen M Jordan,
Kevin D Kallander,
Ko U Min,
LCDR Debra Emerson,
Lei Zhang, PhD,
Maan S Abduldayem,
Maria Joselopez Barragan, PhD,
Mark R Mcclain,
Marlene G Swider,
Maxwell Van Tassell, PhD,
Megan A Haggerty,
Michael R Klapal,
Michael Shanks, MS,
Michelle Yclark Stuart,
Mihaly S Ligmond,
Mra Davism,
Nailing Zhang,
Nealie C Newberger,
Patricia F Hughes, PhD,
Paul L Bellamy,
Prabhu P Raju,
Qiao Y Bobo,
Reyes Candau Chacon, PhD,
Richard Ledwidge (nmi), PhD,
Robert D Tollefsen,
Russell J Glapion,
Ruth Moore, PhD,
Saleem A Akhtar,
Samuel Mindaye,
Sangeeta M Khurana, PhD,
Sean R Marcsisin,
Stacey S Degarmo,
Steven Fong, MS, PhD,
Steven M Weinman,
Susanna E Ford,
Tamara L Ely,
Tamil Arasu, PhD,
Thuy T Nguyen, LCDR,
Truong Xuan Nguyen (Andy),
Wayne E Seifert,
Wendy G Tan, PhD,
William Hallett, PhD,
Yan Wang,
Yetao Jin, PhD,
Yuan Chia Kuo,
Yun Wu, PhD,
Yvesna C Blaise,
Ziyang Su, PhD
Leiyun Boone, PhD's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| March, 2023 | FDA 483 | Rentschler Biopharma SE - Form 483, 2023-03-07 |
| March, 2023 | FDA 483 | Rentschler Biopharma Inc. - Form 483, 2023-03-22 |
| December, 2021 | EIR | Immunex Rhode Island Corporation - EIR, 2021-12-07 |
| June, 2022 | FDA 483 | EirGenix Inc - Form 483, 2022-06-16 |
| December, 2021 | FDA 483 Response | Immunex Rhode Island Corporation - Form 483R, 2021-12-20 |
| July, 2023 | FDA 483 | ImClone Systems LLC - Form 483, 2023-07-27 |
| December, 2021 | FDA 483 | Immunex Rhode Island Corporation - Form 483, 2021-12-07 |
| June, 2023 | EIR | Boehringer Ingelheim Biopharmaceuticals (China) Ltd. - EIR, 2023-12-28 |
| March, 2024 | FDA 483 | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Form 483, 2024-03-19 |
| June, 2023 | FDA 483 | Boehringer Ingelheim Biopharmaceuticals (China) Ltd. - Form 483, 2023-06-09 |
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