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Miriam M. Ngundi

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FDA investigator. Took part in 5 inspections of 5 companies, 2023–2025.

Inspections (5)
DateCompanyClassificationProject areaInspection
November 21, 2025Merck Sharp & Dohme LLCNot classified#1296670
April 29, 2025Axogen CorpNot classified#1277592
July 26, 2024Neurotech Pharmaceuticals, Inc.Not classified#1261691
December 15, 2023Biotest AGNot classified#1238954
January 31, 2023GenIbet Biopharmaceuticals, S.A.VAIVaccines and Allergenic Products#1201486
Documents (4)
  • 483 · Neurotech Pharmaceuticals, Inc. · July 26, 2024
  • 483 · Axogen Corp
  • 483 · Biotest AG
  • 483 · Ultragenyx Pharmaceutical Inc.
Frequently inspected with (10)
Neetu Dahiya
2 shared
Alyssa N. Kitchel
1 shared
Carolina Panico
1 shared
Jin S. Hong
1 shared
Kathleen R. Jones

investigator

1 shared
Kyung E. Sung
1 shared
Lu Deng
1 shared
Nicole M. Li
1 shared
Unnee Ranjan

Investigator

1 shared
Wen J. Seeto

Review Scientist

1 shared
Person Information

Name

Miriam M. Ngundi

Role

ISSUING OFFICER

ID: 3999979f-7a00-4d34-8aed-e4426351c99f

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