Charles Yuan-Chia Kuo
FDA investigator
Appears on 2 documents from 2023 to 2024, mostly at sites in Germany. Most often cites control of microbiological contamination (21 CFR 211.113).
- 2
- Documents on file
- 6.0
- Observations per 483
- 2023
- First seen
- 2024
- Most recent
What they cite most
From 12 observations- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
Activity by year
2023: 1, 2024: 1
Where
Germany 1 · Washington 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-04-30 | 483 CSL Behring GmbHApr 30, 2024 · Marburg, Germany | Marburg, Germany | 7 | |
| 2023-02-10 | 483 AGC Biologics Inc.Feb 10, 2023 · Bothell, Washington | Bothell, Washington | 5 |
About this profile
What does Charles Yuan-Chia Kuo inspect?
Charles Yuan-Chia Kuo appears on 2 documents on file covering 2 sites, mostly in Germany.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.42.
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 Charles Yuan-Chia Kuo is dated Apr 30, 2024.