FDA Investigator Leopold Kong, PhD
Leopold Kong, PhD has conducted inspections on 1 sites in 1 countries as of 25 Feb 2019. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
1
Last Inspection Date:
25 Feb 2019
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Leopold Kong, PhD:
Amy Devlin, PhD,
Ashutosh Rao, PhD,
Bo Chi, PhD,
Bonita S Chester,
Charles Yuanchia Kuo, PhD,
Christopher Downey, PhD,
Devaughn Edwards,
Dr. Zhihao Qiu (Peter), PhD,
Jacek Cieslak, PhD,
Jason F Chancey,
Jee Chung, PhD,
Leslie Arivera Rosado, PhD,
Mary Kaulee,
Patricia F Hughes, PhD,
Paula A Trost,
Penny H Mccarver,
Seneca D Toms,
Simon Williams, PhD,
Sonya M Edmonds,
Steven Fong, MS, PhD,
Thuy T Nguyen, LCDR,
Veronica Fuentes, MS,
Xiaoxiao Pan, PhD,
Xuhong Li,
Yuan Chia Kuo,
Yun Wu, PhD,
Zhenzhen Liu, PhD
Leopold Kong, PhD's Documents
Publish Date | Document Type | Title |
---|---|---|
March, 2019 | FDA 483 | FUJIFILM Diosynth Biotechnologies U.S.A., Inc - Form 483, 2019-03-01 |
March, 2019 | EIR | FUJIFILM Diosynth Biotechnologies U.S.A., Inc - EIR, 2019-03-01 |
March, 2019 | FDA 483 Response | FUJIFILM Diosynth Biotechnologies U.S.A., Inc - Form 483R, 2019-03-21 |
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](/images/InspectorProfile.png)
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