S. Sef Svetlana Shestopal
FDA investigator
Appears on 1 document from 2020, mostly at sites in California. Most often cites control of microbiological contamination (21 CFR 211.113).
- 1
- Documents on file
- 11.0
- Observations per 483
- 2020
- First seen
- 2020
- Most recent
What they cite most
From 11 observations- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.186Master production and control records1
- 21 CFR 600.80Postmarketing reporting of adverse experiences1
Activity by year
2020: 1
Where
California 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-01-17 | 483 BAXALTA US INC.Jan 17, 2020 · THOUSAND OAKS, California | THOUSAND OAKS, California | 11 |
About this profile
What does S. Sef Svetlana Shestopal inspect?
S. Sef Svetlana Shestopal appears on 1 document on file covering 1 site, mostly in California.
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 S. Sef Svetlana Shestopal is dated Jan 17, 2020.