Bo Chi
FDA investigator
Appears on 8 documents from 2013 to 2024, most often at sites in California. Most often cites written procedures; deviations (21 CFR 211.100).
- 8
- Documents on file
- 5.9
- Observations per 483
- 2013
- First seen
- 2024
- Most recent
What they cite most
From 47 observations- 21 CFR 211.100Written procedures; deviations8
- 21 CFR 211.192Production record review7
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.160General requirements3
Activity by year
2013: 1, 2015: 1, 2016: 1, 2018: 1, 2020: 1, 2023: 1, 2024: 2
Where
California 2 · Germany 2 · China 1 · Maryland 1 · Minnesota 1 · North Carolina 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-04-24 | 483 Vetter Pharma Fertigung GmbH & Co. KGApr 24, 2024 · Langenargen, Germany | Langenargen, Germany | 3 | |
| 2024-03-19 | 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Mar 19, 2024 · Ravensburg, Germany | Ravensburg, Germany | 4 | |
| 2023-05-09 | 483 WuXi Biologics Co. Ltd.May 9, 2023 · Wuxi, China | Wuxi, China | 7 | |
| 2020-03-18 | 483 Takeda Pharmaceuticals U.S.A., Inc.Mar 18, 2020 · Brooklyn Park, Minnesota | Brooklyn Park, Minnesota | 3 | |
| 2018-03-16 | 483 Amgen, IncMar 16, 2018 · Thousand Oaks, California | Thousand Oaks, California | 7 | |
| 2016-06-06 | 483 Amgen, IncJun 6, 2016 · Thousand Oaks, California | Thousand Oaks, California | 2 | |
| 2015-05-01 | 483 FUJIFILM Diosynth Biotechnologies U.S.A., IncMay 1, 2015 · North Carolina | North Carolina | 10 |
About this profile
What does Bo Chi inspect?
Bo Chi appears on 8 documents on file covering 7 sites, most often in California.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.192 and 21 CFR 211.67.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Bo Chi is dated Apr 24, 2024.