Marion Michaelis
FDA investigator
Appears on 5 documents from 2016 to 2018, most often at sites in Japan. Most often cites control of microbiological contamination (21 CFR 211.113).
- 5
- Documents on file
- 7.2
- Observations per 483
- 2016
- First seen
- 2018
- Most recent
What they cite most
From 35 observations- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.192Production record review5
- 21 CFR 211.160General requirements4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
Activity by year
2016: 2, 2017: 2, 2018: 1
Where
Japan 2 · Israel 1 · Italy 1 · South Korea 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-01-23 | 483 TOYOBO CO., LTD.Jan 23, 2018 · Otsu, Japan | Otsu, Japan | 5 | |
| 2017-11-13 | 483 Rafa Laboratories Ltd.Nov 13, 2017 · Jerusalem, Israel | Jerusalem, Israel | 6 | |
| 2017-09-01 | 483 Chugai Pharma Manufacturing Co., LtdSep 1, 2017 · Utsunomiya, Japan | Utsunomiya, Japan | 5 | |
| 2016-09-07 | 483 Patheon Italia S.p.ASep 7, 2016 · Ferentino, Italy | Ferentino, Italy | 7 | |
| 2016-06-22 | 483 Samsung Biologics Co., Ltd.Jun 22, 2016 · Incheon, South Korea | Incheon, South Korea | 13 |
About this profile
What does Marion Michaelis inspect?
Marion Michaelis appears on 5 documents on file covering 5 sites, most often in Japan.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.160.
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 Marion Michaelis is dated Jan 23, 2018.