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Melanie N. Daniels

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FDA investigator. Took part in 92 inspections of 85 companies, 2016–2024.

Inspections (92)
DateCompanyClassificationProject areaInspection
April 9, 2024Cheryl M. Burgess, MDNAIBioresearch Monitoring#1237455
March 18, 2024Peta-Gay M. Jackson-Booth, M.D.NAIBioresearch Monitoring#1236092
February 26, 2024Kaiser Permanente of the Mid-Atlantic States IRB #7NAIBioresearch Monitoring#1232973
January 24, 2024Susan L. Stramer, PhDNAIBioresearch Monitoring#1229538
December 12, 2023Elia E. Acevedo DiazNAIBioresearch Monitoring#1226431
November 16, 2023Inova Institutional Review Board (IRB)NAIBioresearch Monitoring#1223654
November 3, 2023Linda R. Duska, M.D.NAIBioresearch Monitoring#1223135
October 11, 2023National Institutes of Health IRBNAIBioresearch Monitoring#1220606
September 22, 2023MacroGenics, IncNAIBioresearch Monitoring#1219746
September 7, 2023Otsuka Pharmaceutical Development & Commercialization, IncNAIBioresearch Monitoring#1219094
August 11, 2023George Mason University IRBNAIBioresearch Monitoring#1216322
July 18, 2023AstraZeneca Pharmaceuticals LPNAIBioresearch Monitoring#1211604
June 22, 2023Alvotech Swiss AGNAIBioresearch Monitoring#1209671
May 11, 2023Medstar Health Research Institute IRBNAIBioresearch Monitoring#1206246
April 7, 2023The George Washington University IRBNot classified#1202779
February 23, 2023Cristina Baldassari, M.D.NAIBioresearch Monitoring#1199366
January 31, 2023Sharleen St. Surin-Lord, M.D.VAIBioresearch Monitoring#1196577
September 9, 2019Vanda Pharmaceuticals IncNAIBioresearch Monitoring#1103014
August 22, 2019C. B. Fleet Company, Inc.NAIBioresearch Monitoring#1102099
July 10, 2019Supernus Pharmaceuticals, Inc.NAIBioresearch Monitoring#1098819
See all 92 inspections in the dashboard
Documents (12)
  • EIR · StageBio · September 3, 2021
  • 483 · Georgetown University IRB · March 11, 2020
  • 483 · Jeffrey S. Dome, M.D. · April 12, 2021
  • 483 · National Institutes of Health IRB · October 11, 2023
  • 483 · Valley Health/Winchester Medical Center IRB · August 9, 2022
  • 483 · Eastern Virginia Medical School IRB · May 3, 2019
  • 483 · StageBio · September 3, 2021
  • 483 · Sharleen St. Surin-Lord, M.D. · January 31, 2023
  • 483 · Ahmed Kaldun Nossuli M.D., Principal Investigator · September 18, 2020
  • 483 · Howard University Institutional Review Board · May 19, 2022
  • 483 · Richard J. Obiso, PhD dba Avila Herbals, LLC · July 26, 2021
  • EIR · Experimental Pathology Laboratories, Inc. · November 13, 2018
Frequently inspected with (10)
David L. Chon

Consumer Safety Officer/BIMO Investigator

6 shared
Hans T. Meyers

investigator

6 shared
Brittany L. Carpenter

investigator

5 shared
Ifueko O. Gardenhire
4 shared
Natalie A. Mickelsen

investigator

3 shared
Young M. Yoon

investigator

3 shared
Brian M. Campbell
2 shared
Corrine M. Carter

investigator

2 shared
Donna K. Speer
2 shared
Lewis K. Antwi
2 shared
Person Information

Name

Melanie N. Daniels

Title

investigator

Role

COMPANY REP

ID: 51d7ddf0-f1af-4e42-ba4c-9a18200f42a9

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