Ephrem Hunde
FDA investigator
Appears on 3 documents from 2016 to 2018, most often at sites in California. Most often cites general requirements (21 CFR 211.160).
- 3
- Documents on file
- 4.7
- Observations per 483
- 2016
- First seen
- 2018
- Most recent
What they cite most
From 14 observations- 21 CFR 211.160General requirements6
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
Activity by year
2016: 1, 2017: 1, 2018: 1
Where
California 1 · Denmark 1 · Italy 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-09-21 | 483 BSP Pharmaceuticals SpASep 21, 2018 · Latina Scalo, Italy | Latina Scalo, Italy | 3 | |
| 2017-04-04 | 483 Boehringer Ingelheim Fremont, Inc.Apr 4, 2017 · Fremont, California | Fremont, California | 10 | |
| 2016-07-08 | 483 FUJIFILM Diosynth Biotechnologies Denmark ApSJul 8, 2016 · Hillerod, Denmark | Hillerod, Denmark | 1 |
About this profile
What does Ephrem Hunde inspect?
Ephrem Hunde appears on 3 documents on file covering 3 sites, most often in California.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.100 and 21 CFR 211.110.
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 Ephrem Hunde is dated Sep 21, 2018.