Dennis J. Hsu, M.D
Form 483 issued March 3, 2026 · Pittsburgh, Pennsylvania
- Inspection
- Feb 10 – Mar 3, 2026
- Investigator
- Brittany M. Kershaw
- Observations
- 1
- Pages
- 2
- FEI number
- 3042047166
In short: On March 3, 2026, FDA issued a Form 483 with 1 observation to Dennis J. Hsu, M.D in Pittsburgh, Pennsylvania (FEI 3042047166) after an inspection that ran Feb 10 – Mar 3, 2026. The investigator was Brittany M. Kershaw. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.60 (1×)
What FDA observed
Preview: the opening words of each observation- 01
An investigation was not conducted in accordance with the…
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 firmDennis J. Hsu, M.D history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dennis J. Hsu, M.D?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators). The opening words of each observation are shown on this page.
Who inspected Dennis J. Hsu, M.D?
Brittany M. Kershaw is named on this Form 483, for the inspection of Feb 10 – Mar 3, 2026. Each investigator has a profile showing what they cite most.
When was Dennis J. Hsu, M.D inspected by FDA?
The inspection ran Feb 10 – Mar 3, 2026, and the Form 483 is dated March 3, 2026.
How do I get the full Form 483 for Dennis J. Hsu, 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.