Overview
- 45 inspections across 45 sites are on record.
- 33 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-10-17.
At a glance
Inspections
45
Sites
45
Observations
33
Career since
Jun 2021
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Vijay S. Iyer, MD, PhD | 17 Oct 2025 | Medical Devices & Rad Health | |
| Temple University Medical IRB, #1 & #2 | 5 Sep 2025 | Medical Devices & Rad Health | |
| Gail J. Roboz, M.D. | 30 Jul 2025 | Human Drugs | |
| Srinivas Rao MyneniVenkatasatya, PhD | 27 Jun 2025 | Medical Devices & Rad Health | View 483 → |
| Claudia A. Chiriboga, MD | 5 Jun 2025 | Human Drugs |
Sites inspected
Vijay S. Iyer, MD, PhDBuffalo, United States1 insp.
Temple University Medical IRB, #1 & #2Philadelphia, United States1 insp.
Gail J. Roboz, M.D.New York, United States1 insp.
Srinivas Rao MyneniVenkatasatya, PhDStony Brook, United States1 insp.
Claudia A. Chiriboga, MDNew York, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Bernardica T Sculac-Stern8 shared
Yuyan Liang3 shared
Samuel A Francis3 shared
Eric J Reisenauer2 shared
Kerun Hardeo1 shared
Ann B Borromeo1 shared
Shamel Jaime1 shared
Byungja E Marciante1 shared
Thomas Cote1 shared
Paul M Gelfand1 shared
Full investigator report
Get the verbatim findings behind Bernardica T Sculac Stern's 33 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site