FDA Person
FDAColleen E. Burke
View detailed information about Colleen E. Burke, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 50 inspections of 50 companies, 2023–2026.
Inspections (50)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 7, 2026 | Frontage Laboratories Inc. | Not classified | #1331644 | |
| July 24, 2026 | Robert A Hozman, M.D. | Not classified | Bioresearch Monitoring | #1327712 |
| July 10, 2026 | Katherine Mathews, M.D. | Not classified | #1326328 | |
| May 20, 2026 | Brett M. Mahon, M.D. | Not classified | #1320100 | |
| April 29, 2026 | Anum Abbas, M.B.B.S | Not classified | #1317022 | |
| April 16, 2026 | Douglas M. Smith, M.D. | Not classified | #1313246 | |
| April 3, 2026 | Astellas Pharma US Inc. | Not classified | #1315968 | |
| March 13, 2026 | IIT Research Institute | Not classified | #1309416 | |
| February 19, 2026 | Robert D. Galiano, MD, FACS | Not classified | #1305280 | |
| January 15, 2026 | Saluda Medical Americas | NAI | Bioresearch Monitoring | #1299850 |
| November 21, 2025 | Anil Kumar, M.D. | NAI | Bioresearch Monitoring | #1295360 |
| November 21, 2025 | Anil Kumar, M.R., M.D. | Not classified | #1295360 | |
| November 17, 2025 | Dr. K. Sudhakar, M.B.B.S. | NAI | Bioresearch Monitoring | #1294886 |
| November 12, 2025 | Sudheer N., M.D. | NAI | Bioresearch Monitoring | #1294140 |
| August 27, 2025 | University of Illinois at Urbana-Champaign IRB | NAI | Bioresearch Monitoring | #1281140 |
| July 29, 2025 | Monica A. Perez, PT, PhD | NAI | Bioresearch Monitoring | #1277836 |
| June 20, 2025 | Michael Schenker | Not classified | #1273822 | |
| June 12, 2025 | Grazyna Pulka | NAI | Bioresearch Monitoring | #1275129 |
| June 6, 2025 | Joanna Gozdzik, M.D | NAI | Bioresearch Monitoring | #1274854 |
| February 20, 2025 | Susanne Schneider-Pils, M.D. | NAI | Bioresearch Monitoring | #1264267 |
Documents (7)
- EIR · AltaThera Pharmaceuticals LLC · June 17, 2022
- 483 · Rachel H. Epstein, M.D. · March 4, 2022
- 483 · Garen Koloyan, M.D., PhD.
- 483 · Randy J. Epstein, M.D. · October 26, 2022
- 483 · Shuo Ma, M.D. · May 6, 2022
- 483 · Manish Jain, M.D. · January 24, 2022
- 483 · AltaThera Pharmaceuticals LLC · June 17, 2022
Person Information
Name
Colleen E. Burke
Title
investigator
Role
COMPANY REP
ID: e013131b-6c14-4a60-b3ab-d8759d38624b
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