FDA Person
Office of Regulatory AffairsKristin M. Abaonza
View detailed information about Kristin M. Abaonza, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of Regulatory Affairs. Took part in 74 inspections of 73 companies, 2016–2026.
Inspections (74)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 28, 2026 | Vivus, LLC. | Not classified | Postmarket Surv. and Epidemiology | #1338264 |
| July 21, 2026 | Endovascular Engineering, Inc | Not classified | Project Evaluation: Devices | #1328782 |
| June 18, 2026 | Florence Lerebours, M.D. | Not classified | Bioresearch Monitoring | #1325474 |
| June 11, 2026 | Antoine Hollebecque, M.D. | NAI | Bioresearch Monitoring | #1325472 |
| May 20, 2026 | Scilex Pharmaceuticals Inc. | Not classified | Postmarket Surv. and Epidemiology | #1318960 |
| May 4, 2026 | Jonathan H. Hughes, M.D. | Not classified | #1315590 | |
| April 3, 2026 | Protagonist Therapeutics Inc | Not classified | Bioresearch Monitoring | #1311710 |
| March 6, 2026 | Ascendis Pharma LLC | Not classified | Postmarketing Surveillance and Epidemiology: Human Drugs | #1306552 |
| March 4, 2026 | Richard A. Lafayette, M.D. | Not classified | Bioresearch Monitoring: Human Drugs | #1305848 |
| January 26, 2026 | Jason Pope, MD | Not classified | #1302550 | |
| December 10, 2025 | Marisa Juntilla, MD, PhD | NAI | Bioresearch Monitoring | #1296302 |
| August 22, 2025 | Pfizer Inc. | NAI | Bioresearch Monitoring | #1279984 |
| August 1, 2025 | Aspirus Wausau Hospital IRB | NAI | Bioresearch Monitoring | #1277660 |
| July 17, 2025 | Phoenix Childrens Hospital IRB | NAI | Bioresearch Monitoring | #1276509 |
| June 13, 2025 | Aleksandra Gilis-Januszewska, M.D. | Not classified | #1273138 | |
| June 6, 2025 | Frederic Caux | VAI | Bioresearch Monitoring: Human Drugs | #1272270 |
| May 19, 2025 | Corcept Therapeutics Incorporated | NAI | Bioresearch Monitoring | #1271321 |
| April 21, 2025 | Stanford University School of Medicine Radioactive Drug Research Committee | Not classified | Bioresearch Monitoring: Human Drugs | #1267751 |
| March 25, 2025 | BioEclipse Therapeutics, Inc. | VAI | Human Cellular, Tissue, and Gene Therapies | #1265444 |
| March 3, 2025 | Cytokinetics, Inc. | NAI | Bioresearch Monitoring | #1263928 |
Documents (41)
- 483 · White House Pharmacy Inc. dba San Jose Compounding Pharmacy · September 14, 2018
- 483 · Geneva Woods Pharmacy Inc · April 16, 2019
- 483 · Reliable Rexall-A Compounding Pharmacy · March 29, 2016
- 483 · One Way Drug, LLC · July 19, 2017
- EIR · Spectrum Laboratory Products, Inc. · November 16, 2018
- EIR · Element Materials Technology Oakland-Concord · December 21, 2018
- 483 · Anish Shah, M.D. · December 16, 2022
- 483 · TriReme Medical, LLC. · October 30, 2019
- EIR · Paul Harmatz, M.D. · November 5, 2020
- 483 · Santa Clara Valley Medical Center IRB · June 3, 2021
- 483 · LimFlow, Inc. · May 15, 2023
- 483 · Kaiser Foundation Research Institute IRB #8 · September 10, 2024
- 483 · Stanford University School of Medicine Radioactive Drug Research Committee · April 21, 2025
- EIR · SanBio, Inc. · March 4, 2022
- EIR · Hessam Aazami, M.D. · February 4, 2020
- EIR · Multidisciplinary Association for Psychedelic Studies · July 26, 2022
- 483 · Boehringer Ingelheim Fremont, Inc. · April 4, 2017
- EIR · Gilead Sciences, Inc. · April 4, 2019
- 483 · VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products · April 17, 2015
- 483 · Hessam Aazami, M.D. · February 4, 2020
- 483 · Neuralink Corporation · June 22, 2023
- 483 · Vanton Research Laboratory, LLC · July 1, 2019
- 483 · Spectrum Laboratory Products, Inc. · November 13, 2018
- 483 · Fred K. Kurata, M.D. · March 30, 2023
- 483 · SRI International · August 9, 2024
- 483 · Jubilant HollisterStier LLC · July 26, 2019
- 483 · Omid Tehrani, M.D. · April 14, 2022
- 483 · M.O.M Enterprises, LLC. · March 20, 2019
- 483 · Daniel Norman, M.D. · September 2, 2020
- 483 · Element Materials Technology Oakland-Concord · December 21, 2018
- 483 · Lykos Therapeutics, Inc. · May 15, 2024
- 483 · Paul Harmatz, M.D. · October 16, 2020
- 483 · CymaBay Therapeutics, Inc. · March 20, 2024
- 483 · Daniel Fred Goodman, M.D. · December 13, 2021
- 483 · Frederic Caux · June 6, 2025
- 483 · Shalini Iyengar, MBBS · May 24, 2024
- 483 · BioEclipse Therapeutics, Inc. · March 25, 2025
- EIR · Lykos Therapeutics, Inc. · May 15, 2024
- 483 · Protagonist Therapeutics Inc · April 3, 2026
- 483 · Scilex Pharmaceuticals Inc. · May 20, 2026
- 483 · Florence Lerebours, M.D. · June 18, 2026
Frequently inspected with (10)
Cynthia J. Tsui
2 shared
Joan T. Briones
Supervisory Consumer Safety Officer
2 shared
John A. Gonzalez
Drug Enforcement Administration
2 shared
Scott N. Lim
2 shared
Alan L. Truong
1 shared
Ashar P. Parikh
1 shared
Christopher M. Jenner
1 shared
Diane L. Raccasi
1 shared
Diane R. Weidley
1 shared
Dustin R. Abaonza
investigator
1 shared
Related Office
Person Information
Name
Kristin M. Abaonza
Role
Regulatory Personnel
ID: cf909da8-837d-4dfe-9ccc-288b24d7bba3
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