FDA Investigator Xiaohui Shen
Xiaohui Shen has conducted inspections on 8 sites in 5 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:
8
Last Inspection Date:
10 Jul 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Sweden,
United States of America,
United Kingdom of Great Britain and Northern Ireland,
Germany,
India
FDA Investigators that have inspected at least one site in common with Xiaohui Shen:
Amanda L Fyles,
Amir Alavi,
Andrew J Brown,
Ashar P Parikh,
Bichsa T Tran,
Binh T Nguyen,
Bruce H Mccullough,
Carla J Lundi,
Carrie A Hughes,
Caryn M Mcnab,
CDR Ileana Barreto Pettit,
Charisse K Green,
Christina Capacci Daniel, PhD,
Colleen F Hoyt,
Crystal Monroy,
Darren S Brown,
David Serrano,
Debra I Love,
Dennis Cantellops Paite,
Doan N Singh,
Dr. Zhihao Qiu (Peter), PhD,
Elizabeth Ad Girard,
Emilie E Kahn,
Emily J Orban,
Erika V Butler,
Feiyan Jin,
Francis A Guidry,
Himanshu Gupta, PhD,
Homero W Aguilar,
Hossein Khorshidi, PhD,
Iris C Macinnes,
James B Arnett,
James L Dunnie, Jr,
James R Fleckenstein,
Jared P Stevens,
Jeffrey P Raimondi,
Jennifer M Gogley,
Jinnie Kokiatkulkij,
Joan A Loreng,
Joey V Quitania,
Jogy George,
John A Gonzalez,
Jolanna A Norton,
Jose A Lopez,
June P Page,
Justin A Boyd,
Kham Phommachanh,
Kim Lthomas Cruse,
Kumar G Janoria,
Lakecha N Lewis,
LCDR Chad N Thompson,
Lillian S Wu,
Lilly O Barton,
Liming Zhang,
Linda Linh N Adams,
Ling Yu L Liu,
Luis Mburgos Medero,
Marcus F Yambot,
Marie F Morin,
Mark C Saale,
Mark R Mcclain,
Mark W Babbitt,
Michael A Charles,
Michael E Maselli,
Michael R Goga,
Michael T Cyrus,
Mra Davism,
Mra Mcculloughj,
Nicholas A Violand,
Pal S Mayasandra,
Patrice S Hall,
Patrick L Wisor,
Philip F Istafanos, DMV, MS,
Rachel C Stanton,
Rebecca Rodriguez,
Richard L Rutherford,
Robert C Coleman,
Roger F Zabinski,
Russell J Glapion,
Samantha J Bradley,
Santiago Gallardo Johnson,
Scott T Ballard,
Sharmista Chatterjee,
Simone E Pitts,
Sonya L Karsik, RAC,
Srinivas R Chennamaneni, PhD,
Steven D Kehoe,
Steven P Donald,
Sue Lee Chan,
Susan M Jackson,
Susan T Hadman,
Susanna E Ford,
Tamala P Bogan,
Tamala P Magee,
Truong Xuan Nguyen (Andy),
Uttaniti Limchumroon (Tom),
Virgilio F Pacio, CSO,
Virginia Carroll, PhD,
Walden H Lee,
Yvonne Y Wu,
Zachary A Bogorad,
Zhong Li, PhD
Xiaohui Shen's Documents
Publish Date | Document Type | Title |
---|---|---|
April, 2019 | FDA 483 | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy - Form 483, 2019-04-05 |
October, 2015 | FDA 483 | Apotek Produktion & Laboratorier AB - Form 483, 2015-10-13 |
October, 2015 | FDA 483 | Apotek Produktion & Laboratorier AB - Form 483, 2015-10-09 |
August, 2023 | FDA 483 | Central Admixture Pharmacy Services Inc - Form 483, 2023-08-25 |
March, 2017 | FDA 483 | Amphastar Pharmaceuticals, Inc. - Form 483, 2017-03-31 |
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