BeOne Medicines USA, Inc
Form 483 issued February 17, 2026 · Pennington, New Jersey
- Inspection
- Feb 9 – Feb 17, 2026
- Investigator
- Jay B. Shah
- Observations
- 1
- Pages
- 3
- FEI number
- 3028672933
In short: On February 17, 2026, FDA issued a Form 483 with 1 observation to BeOne Medicines USA, Inc in Pennington, New Jersey (FEI 3028672933) after an inspection that ran Feb 9 – Feb 17, 2026. The investigator was Jay B. Shah. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.50 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to ensure the study is conducted in accordance with the…
This inspection in context
Jay B. Shah
5 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmBeOne Medicines USA, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BeOne Medicines USA, Inc?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors). The opening words of each observation are shown on this page.
Who inspected BeOne Medicines USA, Inc?
Jay B. Shah is named on this Form 483, for the inspection of Feb 9 – Feb 17, 2026. Each investigator has a profile showing what they cite most.
When was BeOne Medicines USA, Inc inspected by FDA?
The inspection ran Feb 9 – Feb 17, 2026, and the Form 483 is dated February 17, 2026.
How do I get the full Form 483 for BeOne Medicines USA, Inc?
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.