FDA Investigator

Bernardica T Sculac Stern

Latest inspection on record: Buffalo, United States, October 2025 · records back to 2021

Foods & CosmeticsMedical Devices & Rad HealthHuman DrugsBiologics

FDA inspection record · Last updated July 12, 2026

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.

SiteDateCategoryForm 483
Vijay S. Iyer, MD, PhD17 Oct 2025Medical Devices & Rad Health
Temple University Medical IRB, #1 & #25 Sep 2025Medical Devices & Rad Health
Gail J. Roboz, M.D.30 Jul 2025Human Drugs
Srinivas Rao MyneniVenkatasatya, PhD27 Jun 2025Medical Devices & Rad HealthOn file
Claudia A. Chiriboga, MD5 Jun 2025Human 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
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

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