Jae S. Cho, M.D
Form 483 issued December 31, 2025
- Inspection
- Dec 17 – Dec 31, 2025
- Investigator
- Brittany M. Kershaw
- Observations
- 2
- Pages
- 3
- FEI number
- 3040335429
In short: On December 31, 2025, FDA issued a Form 483 with 2 observations to Jae S. Cho, M.D (FEI 3040335429) after an inspection that ran Dec 17 – Dec 31, 2025. The investigator was Brittany M. Kershaw. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 812.100 (general responsibilities of investigators).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 812.100 (1×) · 50.27 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 812.100
An investigation was not conducted according…
- 02
Informed consent was not properly documented in that the written informed consent used in the study…
This inspection in context
Brittany M. Kershaw
2 documents · 2025–2026
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmJae S. Cho, M.D history
The site's inspection history, in date order.
Similar 483sOther sites cited under 50.27
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jae S. Cho, M.D?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 812.100 (general responsibilities of investigators). The opening words of each observation are shown on this page.
Who inspected Jae S. Cho, M.D?
Brittany M. Kershaw is named on this Form 483, for the inspection of Dec 17 – Dec 31, 2025. Each investigator has a profile showing what they cite most.
When was Jae S. Cho, M.D inspected by FDA?
The inspection ran Dec 17 – Dec 31, 2025, and the Form 483 is dated December 31, 2025.
How do I get the full Form 483 for Jae S. Cho, M.D?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.