Jenny Agila Sefen
FDA investigator
Appears on 2 documents from 2015, mostly at sites in Nebraska. Most often cites control of microbiological contamination (21 CFR 211.113).
- 2
- Documents on file
- 13.0
- Observations per 483
- 2015
- First seen
- 2015
- Most recent
What they cite most
From 15 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 211.166Stability testing1
- 21 CFR 211.198Complaint files1
Activity by year
2015: 2
Where
Nebraska 1 · Texas 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2015-10-09 | 483 Downing Labs, LLCOct 9, 2015 · Dallas, Texas | Dallas, Texas | 14 | |
| 2015-07-23 | 483 Essential Pharmacy Compounding LLCJul 23, 2015 · Omaha, Nebraska | Omaha, Nebraska | 12 |
About this profile
What does Jenny Agila Sefen inspect?
Jenny Agila Sefen appears on 2 documents on file covering 2 sites, mostly in Nebraska.
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 Jenny Agila Sefen is dated Oct 9, 2015.