FDA Person
FDADenise L. Burosh
View detailed information about Denise L. Burosh, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 69 inspections of 63 companies, 2016–2024.
Inspections (69)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| November 22, 2024 | J. Scott Ferguson, MD | VAI | Product Evaluation: Medical Devices | #1254795 |
| October 29, 2024 | Promega Corporation | NAI | Bioresearch Monitoring | #1253535 |
| September 18, 2024 | Adriana Estrela, DVM | NAI | Bioresearch Monitoring | #1250898 |
| September 13, 2024 | Alain Gaudric, M.D. | NAI | Bioresearch Monitoring | #1250053 |
| September 6, 2024 | Hakim Charfi | NAI | Bioresearch Monitoring | #1250592 |
| August 23, 2024 | Beverly Tucker Woodson | NAI | Bioresearch Monitoring | #1251896 |
| July 17, 2024 | ProHealth Care IRB | NAI | Bioresearch Monitoring | #1245146 |
| June 27, 2024 | Exact Sciences Corporation | NAI | Bioresearch Monitoring | #1236528 |
| May 23, 2024 | Mehdi Hamadani, M.D | VAI | Bioresearch Monitoring | #1239290 |
| May 3, 2024 | PIL | VAI | Bioresearch Monitoring | #1237533 |
| May 3, 2024 | Mara Piltin, D.O. | VAI | Project Evaluation: Devices | #1237533 |
| March 28, 2024 | Rosa Isela Luna Ceballos, M.D. | NAI | Bioresearch Monitoring | #1235647 |
| March 22, 2024 | Raymundo Garcia Reza, M.D. | NAI | Bioresearch Monitoring | #1236027 |
| February 16, 2024 | Anita D"Souza, M.D. | VAI | Bioresearch Monitoring | #1230064 |
| January 31, 2024 | Padagis US LLC | NAI | Bioresearch Monitoring | #1228870 |
| January 8, 2024 | Lynn Malec, M.D. | VAI | Bioresearch Monitoring | #1226661 |
| November 16, 2023 | Jan Matousek, D.O. | VAI | Bioresearch Monitoring | #1223672 |
| October 24, 2023 | ALLECRA THERAPEUTICS SAS | NAI | Bioresearch Monitoring | #1221694 |
| August 30, 2023 | Labcorp Early Development Laboratories, Inc. | VAI | #1216326 | |
| August 4, 2023 | Office of IRB Administration | NAI | Bioresearch Monitoring | #1217081 |
Documents (34)
- EIR · Faro Ted Owiesy · June 27, 2018
- 483 · Bellin Health System Inc., IRB · May 9, 2019
- 483 · Ascension Health · November 9, 2017
- 483 · Agnesian Healthcare IRB · June 17, 2014
- 483 · Labcorp Clinical Research Unit, Inc. · October 7, 2022
- 483 · PPD Development, L.P.
- 483 · Robert M. Haws, M.D. · September 4, 2020
- 483 · James W. Findling, M.D. · August 26, 2021
- 483 · Surmodics Inc · November 4, 2021
- 483 · Inotiv, Inc. · July 14, 2022
- EIR · Covance Laboratories Inc. · February 14, 2020
- EIR · Alexandra Rogers, MD · October 1, 2021
- EIR · Eli Lilly And Company · January 13, 2022
- 483 · Nancy Kim, M.D. · March 25, 2022
- 483 · D'Alessandro, Anthony M. · June 18, 2021
- EIR · Spaulding Medical LLC · May 31, 2019
- 483 · Labcorp Early Development Laboratories, Inc. · August 20, 2018
- 483 · Spaulding Clinical Research · November 16, 2023
- 483 · Rowena Punzalan, M.D. · January 15, 2021
- 483 · Donald M Brandon MD · February 24, 2023
- 483 · Aspirus Wausau Hospital IRB · December 5, 2019
- 483 · Richy Agajanian, M.D. · March 7, 2019
- EIR · Agnesian Healthcare IRB · June 17, 2014
- EIR · Kleen Test Products Corporation · May 20, 2015
- 483 · J. Scott Ferguson, MD · November 22, 2024
- 483 · James W. Findling, M.D. · August 2, 2019
- 483 · Aukstuolis, Jim G., MD · February 1, 2019
- 483 · Labcorp Early Development Laboratories, Inc. · August 30, 2023
- 483 · American Preclinical Services · May 4, 2011
- EIR · Lazzaro, Marc, MD · March 23, 2015
- 483 · Alexandra Rogers, MD · October 1, 2021
- 483 · Lazzaro, Marc, MD · March 23, 2015
- 483 · Children's Hosp Of WI Institutional Review Board · May 23, 2022
- 483 · Geneva Laboratories, Inc · April 5, 2018
Frequently inspected with (10)
Tawny L. Colling
investigator
2 shared
Camille D. Brown
issuing_officer
1 shared
Cynthia A. Harris
investigator
1 shared
Debra L. Boyd Seale
1 shared
Dina A. Tallman
investigator
1 shared
Eric S. Myskowski
issuing_officer
1 shared
Himanshu Gupta
issuing_officer
1 shared
Kara A. Scheibner
issuing_officer
1 shared
Nicole C. Victoria
investigator
1 shared
Shalonda C. Clifford
1 shared
Person Information
Name
Denise L. Burosh
Title
Bioresearch Monitoring Specialis
Role
Regulatory Personnel
ID: 075a442f-67e0-4a65-9c09-e8819a329773
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