FDA Person
FDABernardica T. Sculac Stern
View detailed information about Bernardica T. Sculac Stern, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 31 inspections of 31 companies, 2023–2025.
Inspections (31)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| October 17, 2025 | Vijay S. Iyer, MD, PhD | Not classified | #1288720 | |
| September 5, 2025 | Temple University Medical IRB, #1 & #2 | NAI | Bioresearch Monitoring | #1281844 |
| July 30, 2025 | Gail J. Roboz, M.D. | NAI | Bioresearch Monitoring | #1278123 |
| June 27, 2025 | Srinivas Rao MyneniVenkatasatya, PhD | VAI | Product Evaluation: Medical Devices | #1273974 |
| June 5, 2025 | Claudia A. Chiriboga, M.D. | Not classified | #1273570 | |
| April 30, 2025 | Hospital For Special Surgery IRB | NAI | Bioresearch Monitoring | #1270518 |
| April 3, 2025 | Jed C. Kaminetsky, M.D. | NAI | Bioresearch Monitoring | #1267085 |
| March 10, 2025 | Michael G. Kaplitt, MD, PhD. | Not classified | #1264377 | |
| February 14, 2025 | Rachel N. Grisham, M.D. | NAI | Bioresearch Monitoring | #1261942 |
| January 24, 2025 | Elaine Shum, M.D. | Not classified | #1259643 | |
| December 12, 2024 | Roger S. Keresztes, M.D. | VAI | Bioresearch Monitoring: Human Drugs | #1256353 |
| November 12, 2024 | Paula J. Busse, M.D. | Not classified | #1255227 | |
| October 10, 2024 | Michael J. Schwartz, M.D. | NAI | Bioresearch Monitoring | #1252786 |
| September 13, 2024 | Rochester Regional Health IRB | Not classified | #1250478 | |
| July 19, 2024 | James J. Harding, M.D. | NAI | Bioresearch Monitoring | #1244742 |
| June 28, 2024 | LifeBridge Health, Inc. IRB | NAI | Bioresearch Monitoring | #1244246 |
| June 11, 2024 | Alison M. Schram, M.D. | NAI | Bioresearch Monitoring | #1242625 |
| May 16, 2024 | Richard G. Moore, M.D. | NAI | Bioresearch Monitoring | #1239974 |
| May 9, 2024 | New York Medical College, Committee for Protection of Human Subjects | NAI | Bioresearch Monitoring | #1240945 |
| April 8, 2024 | Maria L. Palomba, M.D. | NAI | Bioresearch Monitoring | #1237227 |
Documents (1)
- 483 · Roger S. Keresztes, M.D. · December 12, 2024
Frequently inspected with (5)
Person Information
Name
Bernardica T. Sculac Stern
Role
ISSUING OFFICER
ID: 44ff2730-4410-4b72-819c-4b90e8904f33
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