Jie He
FDA investigator
Appears on 6 documents from 2023 to 2025, most often at sites in North Carolina. Most often cites written procedures; deviations (21 CFR 211.100).
- 6
- Documents on file
- 4.5
- Observations per 483
- 2023
- First seen
- 2025
- Most recent
What they cite most
From 27 observations- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
Activity by year
2023: 2, 2024: 2, 2025: 2
Where
North Carolina 2 · Ireland 1 · Massachusetts 1 · Texas 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-03-11 | 483 Fujifil m Diosyn th Biotechnologies Texas, LLCMar 11, 2025 · College Station, Texas | College Station, Texas | 8 | |
| 2025-01-30 | 483 Allergan Pharmaceuticals Ireland UnlimitedJan 30, 2025 · Westport, Ireland | Westport, Ireland | 5 | |
| 2024-07-12 | 483 FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024Jul 12, 2024 | — | 2 | |
| 2024-02-16 | 483 RTP Operating, LLCFeb 16, 2024 · Durham, North Carolina | Durham, North Carolina | 5 | |
| 2023-11-10 | 483 FDA Form 483 Pfizer, Sanford, NC Nov 2023Nov 10, 2023 · Sanford, North Carolina | Sanford, North Carolina | 1 | |
| 2023-01-20 | 483 Berkshire Sterile Manufacturing (BSM)Jan 20, 2023 · Lee, Massachusetts | Lee, Massachusetts | 6 |
About this profile
What does Jie He inspect?
Jie He appears on 6 documents on file covering 6 sites, most often in North Carolina.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.160 and 21 CFR 211.192.
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 Jie He is dated Mar 11, 2025.