Jean Hu-Primmer
FDA investigator
Appears on 2 documents from 2018, mostly at sites in Michigan. Most often cites production record review (21 CFR 211.192).
- 2
- Documents on file
- 1.0
- Observations per 483
- 2018
- First seen
- 2018
- Most recent
What they cite most
From 8 observations- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
Activity by year
2018: 2
Where
Michigan 1 · North Carolina 1
Often inspects with
Is Jean Hu-Primmer coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-09-27 | 483 Emergent Biodefense Operations Lansing LLCSep 27, 2018 · Lansing, Michigan | Lansing, Michigan | 1 | |
| 2018-06-18 | 483 Seqirus IncJun 18, 2018 · Holly Springs, North Carolina | Holly Springs, North Carolina | — |
About this profile
What does Jean Hu-Primmer inspect?
Jean Hu-Primmer appears on 2 documents on file covering 2 sites, mostly in Michigan.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.22 and 21 CFR 211.100.
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 Jean Hu-Primmer is dated Sep 27, 2018.