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Ekaterina Allen

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FDA investigator. Took part in 6 inspections of 6 companies, 2019–2025.

Inspections (6)
DateCompanyClassificationProject areaInspection
July 4, 2025Alvotech HFNot classified#1286888
February 18, 2025Patheon Italia S.p.ANot classified#1269289
August 30, 2024Patheon Manufacturing Services LLCNot classified#1271322
July 16, 2024Catalent Anagni SRLNot classified#1251176
May 31, 2024AstraZeneca Pharmaceuticals LPVAIDrug Quality Assurance#1238346
August 2, 2019Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell LaboratoryNot classified#1110495
Documents (8)
  • 483 · Patheon Italia S.p.A · February 18, 2025
  • 483 · Catalent Anagni SRL · July 16, 2024
  • 483 · AstraZeneca Pharmaceuticals LP · May 31, 2024
  • 483 · Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell Laboratory · August 2, 2019
  • 483 · Alvotech HF. · July 4, 2025
  • 483 · Patheon Manufacturing Services LLC · August 30, 2024
  • 483 · Alvotech HF · July 4, 2025
  • 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · July 23, 2021
Frequently inspected with (10)
Zhong Li
2 shared
Della Shin

Pharmaceutical Scientist

1 shared
Hyung-yul Lee
1 shared
James R. Birkenstamm
1 shared
Jazmine N. Brown
1 shared
Kathryn E. King
1 shared
Leiyun W. Boone

Lead Biologist

1 shared
Lily Y. Koo
1 shared
Prabhu P. Raju

Program Expert for Advanced Manufacturing

1 shared
Randa Melhem

investigator

1 shared
Person Information

Name

Ekaterina Allen

Title

Pharmaceutical Scientist

Role

INVESTIGATOR

ID: 760a7817-8e5b-45f9-82ee-db6ca139a92e

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