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Theressa B. Smith

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FDA investigator. Took part in 71 inspections of 71 companies, 2016–2026.

Inspections (71)
DateCompanyClassificationProject areaInspection
September 25, 2026Aytu Biopharma, Inc.Not classifiedPostmarket Surv. and Epidemiology#1338580
August 14, 2026Attentive Science LLCNot classifiedBioresearch Monitoring#1331146
July 27, 2026Blake G. Simmons, ODNot classifiedBioresearch Monitoring#1328180
June 25, 2026Breelyn A Wilky MDNot classifiedBioresearch Monitoring#1323706
June 18, 2026Dr. Amira Al-Uzri, M.D.Not classifiedBioresearch Monitoring#1323272
April 24, 2026Anuj Bhargava MDNot classifiedBioresearch Monitoring#1314648
March 20, 2026Rishi K. Wadhwa, M.D.Not classifiedProduct Evaluation: Medical Devices#1308694
February 13, 2026Kevin E. Miller, MDNot classifiedProduct Evaluation: Medical Devices#1303334
December 19, 2025Novocure GmbHNot classified#1298666
December 12, 2025Johanna WilminkNot classified#1302278
November 24, 2025Synergy Spine Solutions, Inc.VAIProduct Evaluation: Medical Devices#1292868
October 9, 2025Edmundowicz, Dr StevenVAIProduct Evaluation: Medical Devices#1287220
August 26, 2025Bronco Research Services dba inotiv Fort CollinsVAIBioresearch Monitoring: Human Drugs#1279657
July 28, 2025Laura Kooienga, M.D.Not classified#1277662
June 18, 2025David Pham, M.D.Not classifiedBioresearch Monitoring: Human Drugs#1273246
April 24, 2025Shaila U. Gogate, M.D.VAIBioresearch Monitoring: Human Drugs#1267883
March 14, 2025Dr. Song Qu, MDNot classified#1264771
March 7, 2025Akeso-Sino Pharma Co., Ltd.Not classified#1266119
February 7, 2025Jean F. Botha, M.D.VAIProduct Evaluation: Medical Devices#1260341
January 24, 2025Melamed, Isaac R. , M.D.VAIBioresearch Monitoring: Human Drugs#1259304
See all 71 inspections in the dashboard
Documents (58)
  • 483 · Bronco Research Services dba inotiv Fort Collins · August 26, 2025
  • 483 · David Pham, M.D. · June 18, 2025
  • 483 · Patel, Vikas V. · December 17, 2019
  • 483 · Citrogein (Div of GVK Biosciences) · March 13, 2015
  • 483 · Redbeast Enterprises Inc dba High Quality Research · February 27, 2023
  • 483 · GVK Biosciences Pvt. Ltd. · March 13, 2015
  • 483 · Barbara E. Rizzardi, MD · December 2, 2022
  • 483 · HEATHER R. HARRISON, D.O. · September 19, 2018
  • 483 · National Jewish Health · March 9, 2020
  • 483 · Edmundowicz, Dr Steven · October 9, 2025
  • 483 · Neurocrine Biosciences Inc · July 18, 2024
  • 483 · PharmaLegacy Research LLC · July 8, 2022
  • EIR · National Jewish Health · March 9, 2020
  • EIR · GVK Biosciences Pvt. Ltd. · March 13, 2015
  • 483 · Clinogent (Div of GVK Biosciences) · March 13, 2015
  • EIR · Esoterix Clinical Trials Services · June 27, 2018
  • 483 · Laura A. Nussbaum, M.D. · December 6, 2024
  • 483 · Melamed, Isaac R. , M.D. · January 24, 2025
  • 483 · Shaila U. Gogate, M.D. · April 24, 2025
  • 483 · Jean F. Botha, M.D. · February 7, 2025
  • 483 · Bronco Research Services dba inotiv Fort Collins · August 26, 2025
  • EIR · Cochlear Americas Inc. · February 22, 2018
  • 483 · Barrett E. Cowan, MD · February 5, 2019
  • 483 · Lewis, Karl D. MD · August 7, 2023
  • 483 · Sanitation & Environmental Technology Institute · March 15, 2024
  • 483 · Karsh, Lawrence, M.D. · July 16, 2020
  • 483 · Jeffrey W. Groves, M.D. · April 4, 2019
  • 483 · Janet Thomas, M.D. · November 27, 2017
  • 483 · Creighton University IRB · April 7, 2022
  • 483 · Michael W. Harris, D.O. · May 24, 2019
  • 483 · Ryan M. Rich, M.D. · July 29, 2019
  • 483 · Namita A. Goyal, M.D. · June 23, 2023
  • 483 · HMS Veterinary Development Inc · March 4, 2022
  • 483 · Nancy A. Krywonis, M.D. · July 23, 2021
  • 483 · Nicola Longo, M.D., Ph.D. · March 10, 2023
  • 483 · Arthur R. Cabrera, M.D. · May 16, 2023
  • 483 · Southwest Bio-Labs, Inc. · March 19, 2020
  • 483 · Cochlear Americas Inc. · October 21, 2021
  • 483 · Colorado Histo-Prep · May 10, 2013
  • 483 · Lovelace Biomedical Research Institute · January 27, 2020
  • 483 · David Young, D.O. · December 19, 2017
  • 483 · Sanitation & Environmental Technology Institute · March 15, 2024
  • 483 · Jayant Kumar, M.D. · May 10, 2021
  • 483 · Lovelace Biomedical Research Institute · November 11, 2016
  • 483 · Esoterix Clinical Trials Services · June 27, 2018
  • 483 · Smitha Reddy, M.D. · August 20, 2021
  • 483 · Cochlear Americas Inc. · February 22, 2018
  • EIR · Lovelace Biomedical Research Institute · January 31, 2020
  • 483 · Samm Solutions, Inc (dba) BTS Research · July 8, 2022
  • 483 · Mark Dacey, M.D. · November 8, 2024
  • 483 · Kevin E. Miller, MD · February 13, 2026
  • 483 · Synergy Spine Solutions, Inc. · November 24, 2025
  • 483 · Rishi K. Wadhwa, M.D. · March 20, 2026
  • 483 · Dr. Amira Al-Uzri, M.D. · June 18, 2026
  • 483 · Breelyn A Wilky MD · June 25, 2026
  • 483 · Blake G. Simmons, OD · July 27, 2026
  • 483 · Attentive Science LLC · August 14, 2026
  • EIR · David Pham, M.D. · June 18, 2025
Frequently inspected with (10)
Stephen T. Hansen

investigator

3 shared
Annabelle Crusan
2 shared
Brandy D. Brown
2 shared
Dawn C. Olenjack
2 shared
Jonathan R. Campos
2 shared
Ruth A. Williams

issuing_officer

2 shared
Shuliang Li
2 shared
Tawny L. Colling

investigator

2 shared
David L. Chon

Consumer Safety Officer/BIMO Investigator

1 shared
Gavin W. Pierce
1 shared
Person Information

Name

Theressa B. Smith

Role

ISSUING OFFICER

ID: 80f0c339-7eac-4c73-b9f6-ecb368738fe6

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