Sarah Arden
FDA investigator
Appears on 2 documents from 2017, mostly at sites in California. Most often cites written procedures; deviations (21 CFR 211.100).
- 2
- Documents on file
- 4.5
- Observations per 483
- 2017
- First seen
- 2017
- Most recent
What they cite most
From 9 observations- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
Activity by year
2017: 2
Where
California 1 · South Korea 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-07-25 | 483 Samsung BioLogicsJul 25, 2017 · Yeonsu-gu, South Korea | Yeonsu-gu, South Korea | 4 | |
| 2017-05-16 | 483 Amgen, IncMay 16, 2017 · Thousand Oaks, California | Thousand Oaks, California | 5 |
About this profile
What does Sarah Arden inspect?
Sarah Arden appears on 2 documents on file covering 2 sites, mostly in California.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.160 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 Sarah Arden is dated Jul 25, 2017.