Orthis Pron Rose Xu
FDA investigator
Appears on 1 document from 2018, mostly at sites in China. Most often cites sampling and testing of in-process materials and drug products (21 CFR 211.110).
- 1
- Documents on file
- 4.0
- Observations per 483
- 2018
- First seen
- 2018
- Most recent
What they cite most
From 4 observations- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
Activity by year
2018: 1
Where
China 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-04-03 | 483 Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site)Apr 3, 2018 · Nanjing, China | Nanjing, China | 4 |
About this profile
What does Orthis Pron Rose Xu inspect?
Orthis Pron Rose Xu appears on 1 document on file covering 1 site, mostly in China.
What do they cite most often?
21 CFR 211.110 (sampling and testing of in-process materials and drug products), followed by 21 CFR 211.113 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 Orthis Pron Rose Xu is dated Apr 3, 2018.