FDA Person
FDABo Chi
View detailed information about Bo Chi, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 11 inspections of 11 companies, 2017–2024.
Inspections (11)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| April 24, 2024 | Vetter Pharma Fertigung GmbH & Co. KG | Not classified | #1234265 | |
| March 19, 2024 | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Not classified | #1242049 | |
| March 14, 2019 | Merz Pharma GmbH & Co., KGaA | Not classified | #1088213 | |
| February 12, 2019 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Not classified | #1084340 | |
| October 9, 2018 | Patheon Biologics LLC | Not classified | #1072763 | |
| May 15, 2018 | Exelead, Inc. | Not classified | #1055813 | |
| March 16, 2018 | Amgen, Inc. | Not classified | #1046609 | |
| September 27, 2017 | Chugai Pharmaceutical Co., Ltd. | Not classified | #1029759 | |
| August 2, 2017 | Wuxi Biologics Co Ltd | Not classified | #1028829 | |
| May 2, 2017 | BioMarin International Limited | Not classified | #1010352 | |
| January 27, 2017 | Amgen Singapore Manufacturing Pte Ltd | Not classified | #998776 |
Documents (21)
- 483 · Novartis d.o.o. · July 21, 2023
- EIR · Rentschler Biopharma SE · February 15, 2022
- EIR · Shanghai Henlius Biologics Co., Ltd. · March 11, 2025
- EIR · UCB Pharma S.A. · February 4, 2022
- EIR · Lonza Biologics Porrino SL · September 13, 2016
- EIR · Genentech, Inc. · June 27, 2012
- 483 · BioMarin International Limited · May 2, 2017
- 483 · BioMarin International Limited
- 483 · Amgen, Inc.
- 483 · GlaxoSmithKline dba Human Genome Sciences Inc · April 26, 2013
- 483 · Wuxi Biologics Co Ltd · May 9, 2023
- 483 · Vetter Pharma Fertigung GmbH & Co. KG · April 24, 2024
- 483 · Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) · March 19, 2024
- 483 · Nang Kuang Pharmaceutical Co., Ltd. · June 16, 2022
- 483 · FujiFilm Diosynth Biotechnologies U.S.A., Inc. · May 1, 2015
- 483 · Patheon Biologics LLC
- 483 · Amgen, Inc.
- 483 · Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 · March 11, 2025
- 483 · Shanghai Henlius Biologics Co., Ltd. · March 11, 2025
- 483 · Biovectra Inc. · September 12, 2024
- 483 · Chugai Pharma Manufacturing Co. Ltd. (CPMC)
Frequently inspected with (10)
Anita Narula
Compliance Officer - CDER/OC/OMQ
1 shared
Christopher T. Middendorf
Senior Director Technical
1 shared
Jazmine N. Brown
1 shared
Kathleen R. Jones
investigator
1 shared
Lakshmi Ran Narasimhan
1 shared
Marion Michaelis
1 shared
Maxwell L. Van Tassell
1 shared
Olumide A. Martins
1 shared
Reyes Candau-Chacon
Microbiologist
1 shared
Steven Fong
Microbiologist
1 shared
Person Information
Name
Bo Chi
Role
ISSUING OFFICER
ID: 0016303e-704f-4a0a-ad1d-6ae4efdc1b19
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