FDA Person
Office of Regulatory AffairsXikui Chen
View detailed information about Xikui Chen, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of Regulatory Affairs. Took part in 18 inspections of 18 companies, 2017–2023.
Inspections (18)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| July 28, 2023 | QUOTIENT SCIENCES (ALNWICK) LIMITED | NAI | Bioresearch Monitoring | #1221237 |
| June 9, 2023 | AnaZeal Analyticals & Research Pvt Ltd | NAI | Bioresearch Monitoring | #1209606 |
| April 21, 2023 | Sciegen Pharmaceuticals Inc | OAI | Bioresearch Monitoring | #1204858 |
| August 16, 2019 | Sinotherapeutics Inc. | NAI | Bioresearch Monitoring | #1102346 |
| March 21, 2019 | Aurigene Pharmaceutical Services Limited | NAI | Bioresearch Monitoring | #1089349 |
| March 15, 2019 | Watson Pharma Private Ltd. | NAI | Bioresearch Monitoring | #1086666 |
| December 14, 2018 | Solara Active Pharma Sciences Limited | NAI | Bioresearch Monitoring | #1077338 |
| December 7, 2018 | Apotex Research Private Limited | NAI | Bioresearch Monitoring | #1077347 |
| August 3, 2018 | Cliantha Research Ltd. | NAI | Bioresearch Monitoring | #1066355 |
| July 27, 2018 | Ecron Acunova Limited | NAI | Bioresearch Monitoring | #1065594 |
| February 16, 2018 | Lambda Therapeutic Research Ltd. | NAI | Bioresearch Monitoring | #1048382 |
| February 9, 2018 | Synchron Research Services Pvt. Ltd. | NAI | Bioresearch Monitoring | #1047625 |
| December 15, 2017 | Across Barriers GmbH | Not classified | #1038556 | |
| July 21, 2017 | Lupin Limited | Not classified | #1025679 | |
| July 14, 2017 | Cadila Pharmaceuticals Limited | Not classified | #1019141 | |
| May 12, 2017 | Pharmaceutical Research Associates Group B.V. | Not classified | #1017116 | |
| May 4, 2017 | Sanquin Diagnostic Services | Not classified | #1014277 | |
| February 10, 2017 | WuXi AppTec Co., Ltd. | Not classified | #1003744 |
Documents (5)
- 483 · Cetero Research · December 10, 2010
- 483 · Sciegen Pharmaceuticals Inc · April 17, 2023
- EIR · Frontage Laboratories Shanghai Co., Ltd. · August 9, 2013
- 483 · PRACS Institute, Ltd. · August 6, 2012
- EIR · Inotiv Inc · March 8, 2013
Frequently inspected with (8)
Sripal R. Mada
investigator
4 shared
Li-Hong Yeh
2 shared
Melkamu Getie Kebtie
2 shared
Michael F. Skelly
issuing_officer
2 shared
Courtney N. Long
investigator
1 shared
Jennifer C. Adams
issuing_officer
1 shared
Mohsen Rajabi Abhari
1 shared
Susanne M. Richardson
investigator
1 shared
Related Office
Person Information
Name
Xikui Chen
Title
Pharmacologist at FDA
Role
Regulatory Personnel
ID: b320acb8-c976-4b42-bfdb-95b1701e7627
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