Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke
Form 483 issued March 20, 2026 · Pudong New Area, China
- Inspection
- Mar 9 – Mar 20, 2026
- Investigator
- Richard W. Berning
- Observations
- 1
- Pages
- 2
- FEI number
- 3020982471
In short: On March 20, 2026, FDA issued a Form 483 with 1 observation to Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke in Pudong New Area, China (FEI 3020982471) after an inspection that ran Mar 9 – Mar 20, 2026. The investigator was Richard W. Berning. 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
Richard W. Berning
3 documents · 2016–2026
Cites 312.50 (general responsibilities of sponsors) more than any other section. Most of their documents are for sites in China.
The firmAbbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke 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 Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke?
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 Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke?
Richard W. Berning is named on this Form 483, for the inspection of Mar 9 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke inspected by FDA?
The inspection ran Mar 9 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, Huanke?
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.