Mikhail Ovanesov
FDA investigator
Appears on 4 documents from 2016 to 2023, most often at sites in Austria. Most often cites control of microbiological contamination (21 CFR 211.113).
- 4
- Documents on file
- 3.3
- Observations per 483
- 2016
- First seen
- 2023
- Most recent
What they cite most
From 11 observations- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.42Design and construction features1
Activity by year
2016: 2, 2022: 1, 2023: 1
Where
Austria 1 · Denmark 1 · Sweden 1 · Washington 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-05-04 | 483 Novo Nordisk A/SMay 4, 2023 · Kalundborg, Denmark | Kalundborg, Denmark | 3 | |
| 2022-06-24 | 483 Takeda Manufacturing Austria AGJun 24, 2022 · WIEN, Austria | WIEN, Austria | 3 | |
| 2016-10-03 | 483 Octapharma ABOct 3, 2016 · Stockholm, Sweden | Stockholm, Sweden | — | |
| 2016-04-22 | 483 AGC Biologics, Inc.Apr 22, 2016 · Bothell, Washington | Bothell, Washington | 4 |
About this profile
What does Mikhail Ovanesov inspect?
Mikhail Ovanesov appears on 4 documents on file covering 4 sites, most often in Austria.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.100.
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 Mikhail Ovanesov is dated May 4, 2023.