Wuxi Biologics Ireland Limited Dundalk Science and Technology Park
Form 483 issued December 16, 2025 · Mullagharlin, Ireland
- Inspection
- Dec 8 – Dec 16, 2025
- Investigators
- Dilip Devineni· Liqun Zhao
- Observations
- 3
- Pages
- 2
- FEI number
- 3026506583
In short: On December 16, 2025, FDA issued a Form 483 with 3 observations to Wuxi Biologics Ireland Limited Dundalk Science and Technology Park in Mullagharlin, Ireland (FEI 3026506583) after an inspection that ran Dec 8 – Dec 16, 2025. The investigators were Dilip Devineni and Liqun Zhao. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
ow equipment utilized in the gw drug substance…
- 02
Laboratory controls are inadequate to ensure reliable analytical testing of critical…
This inspection in context
Dilip Devineni
1 document · 2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Ireland.
The firmWuxi Biologics Ireland Limited Dundalk Science and Technology Park history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wuxi Biologics Ireland Limited Dundalk Science and Technology Park?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Wuxi Biologics Ireland Limited Dundalk Science and Technology Park?
Dilip Devineni and Liqun Zhao are named on this Form 483, for the inspection of Dec 8 – Dec 16, 2025. Each investigator has a profile showing what they cite most.
When was Wuxi Biologics Ireland Limited Dundalk Science and Technology Park inspected by FDA?
The inspection ran Dec 8 – Dec 16, 2025, and the Form 483 is dated December 16, 2025.
How do I get the full Form 483 for Wuxi Biologics Ireland Limited Dundalk Science and Technology Park?
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.