Overview
- 7 inspections across 7 sites are on record.
- 4 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-07-04.
At a glance
Inspections
7
Sites
7
Observations
4
Career since
Aug 2019
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Alvotech HF | 4 Jul 2025 | Human Drugs | On file |
| Patheon Italia S.p.A | 18 Feb 2025 | Human Drugs | On file |
| Patheon Manufacturing Services LLC | 30 Aug 2024 | Human Drugs | On file |
| Catalent Anagni SRL | 16 Jul 2024 | Human Drugs | On file |
| AstraZeneca Pharmaceuticals LP | 31 May 2024 | Human Drugs | View 483 → |
Sites inspected
Alvotech HFReykjavik, Iceland1 insp.
Patheon Italia S.p.AFerentino, Italy1 insp.
Patheon Manufacturing Services LLCRidgefield, United States1 insp.
Catalent Anagni SRLAnagni, Italy1 insp.
AstraZeneca Pharmaceuticals LPGaithersburg, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Zhong Li2 shared
Leiyun W Boone1 shared
Della Shin1 shared
Hyung-Yul Lee1 shared
Kathryn E King1 shared
Wayne E Seifert1 shared
Jazmine N Brown1 shared
Ruo H Xu1 shared
Thuy T Nguyen1 shared
James R Birkenstamm1 shared
Full investigator report
Get the verbatim findings behind Ekaterina Allen's 4 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site