Ekaterina Allen
FDA investigator
Appears on 6 documents from 2021 to 2025, most often at sites in Italy. Most often cites control of microbiological contamination (21 CFR 211.113).
- 6
- Documents on file
- 7.8
- Observations per 483
- 2021
- First seen
- 2025
- Most recent
What they cite most
From 39 observations- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.192Production record review5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.100Written procedures; deviations3
Activity by year
2021: 2, 2024: 2, 2025: 2
Where
Italy 2 · Massachusetts 2 · Iceland 1 · Maryland 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-07-04 | 483 Alvotech HfJul 4, 2025 · Reykjavik, Iceland | Reykjavik, Iceland | 10 | |
| 2025-02-18 | 483 Thermo Fisher ScientificFeb 18, 2025 · Ferentino, Italy | Ferentino, Italy | 6 | |
| 2024-07-16 | 483 Catalent Anagni S.R.L.Jul 16, 2024 · ANAGNI, Italy | ANAGNI, Italy | 6 | |
| 2024-05-31 | 483 AstraZeneca Pharmaceuticals LPMay 31, 2024 · Gaithersburg, Maryland | Gaithersburg, Maryland | 4 | |
| 2021-07-23 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCJul 23, 2021 · Andover, Massachusetts | Andover, Massachusetts | 13 | |
| 2021-07-23 | EIR Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCJul 23, 2021 · Andover, Massachusetts | Andover, Massachusetts | — |
About this profile
What does Ekaterina Allen inspect?
Ekaterina Allen appears on 6 documents on file covering 5 sites, most often in Italy.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.42 and 21 CFR 211.192.
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 Ekaterina Allen is dated Jul 4, 2025.