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Michelle J. Hines

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FDA investigator. Took part in 69 inspections of 67 companies, 2016–2026.

Inspections (69)
DateCompanyClassificationProject areaInspection
February 9, 2026Rosa A. TangNot classified#1302542
January 30, 2026Amin Al-Ahmad, M.DNAIBioresearch Monitoring#1301018
December 19, 2025Naval Daver, M.D.Not classified#1297496
September 12, 2025Michelle D. Welch, M.D.Not classified#1287794
February 26, 2024Abdullah Mubarak, M.D.VAIBioresearch Monitoring#1231038
January 31, 20243D Imaging Drug Design and DevelopmentVAIBioresearch Monitoring#1228168
November 2, 2023Hernan Salazar-Seymour, DO, MPHNAIBioresearch Monitoring#1222554
September 15, 2023Paul S. Thornton, M.D.NAIBioresearch Monitoring#1220613
January 30, 2023Michael S. Hisey, M.D.NAIBioresearch Monitoring#1196834
January 12, 2023Marek SmilowskiNAIBioresearch Monitoring#1197431
September 18, 2019Daniel E. Grosz, MDNAIBioresearch Monitoring#1103463
August 22, 2019Peter J. Winkle M.D.NAIBioresearch Monitoring#1100776
August 14, 2019Randy I. Cooper, MDNAIBioresearch Monitoring#1099752
August 2, 2019David R. Hensley, MDVAIBioresearch Monitoring#1098388
June 26, 2019Sung Hye Yi, PhDNAIBioresearch Monitoring#1096160
June 26, 2019Austina B. Cho, M.D.NAIBioresearch Monitoring#1095931
June 5, 2019Celerion Inc.VAIBioresearch Monitoring#1093485
May 17, 2019Abram H. Burgher, MDNAIBioresearch Monitoring#1090529
April 18, 2019Insys Therapeutics IncNAIBioresearch Monitoring#1089685
April 5, 2019James F. PehoushekNAIBioresearch Monitoring#1087863
See all 69 inspections in the dashboard
Documents (16)
  • EIR · Joseph McCready, MD · May 9, 2017
  • EIR · Mark Gotfried, M.D · June 1, 2021
  • EIR · Genentech, Inc. · October 7, 2022
  • 483 · James E. Cain, M.D. · August 27, 2021
  • 483 · Joseph L. Lillo, D.O. · March 22, 2021
  • EIR · Imaging Endpoints II, LLC. · June 7, 2018
  • 483 · Rafaelito S. Victoria, MD · September 25, 2020
  • 483 · Northfelt, Donald MD · December 14, 2018
  • 483 · David R. Hensley, MD · August 2, 2019
  • 483 · George R. Reiss, MD · September 29, 2016
  • 483 · Neil Sheth, MD · November 24, 2020
  • 483 · Robert Nelson, M.D., Ph.D. · October 23, 2019
  • 483 · 3D Imaging Drug Design and Development · January 31, 2024
  • 483 · Joseph L. Lillo, D.O. · December 9, 2019
  • EIR · Celerion Inc. · June 5, 2019
  • EIR · Mitesh Borad, MD · October 24, 2017
Frequently inspected with (5)
Brandy D. Brown
2 shared
Ronda R. Loyd Jones
2 shared
Andrea A. Branche

CSO

1 shared
Anya D. Lockett-Evans
1 shared
Damon C. Green
1 shared
Person Information

Name

Michelle J. Hines

Title

issuing_officer

Role

COMPANY REP

ID: c8087e41-6b8a-4b9a-92ad-bba500ce6fee

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