Allergan Pharmaceuticals Ireland Unlimited
Form 483 issued January 30, 2025 · Westport, Ireland
- Inspection
- Jan 23 – Jan 30, 2025
- Investigators
- Jie He· Kejun Cheng· Thuy T. Nguyen
- Observations
- 5
- Pages
- 2
- FEI number
- 3002806285
In short: On January 30, 2025, FDA issued a Form 483 with 5 observations to Allergan Pharmaceuticals Ireland Unlimited in Westport, Ireland (FEI 3002806285) after an inspection that ran Jan 23 – Jan 30, 2025. The investigators were Jie He, Kejun Cheng and Thuy T. Nguyen. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your examination and testing of samples did not assure that the drug product and in-process…
- 02
The establishment of laboratory…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jie He
6 documents · 2023–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in North Carolina.
The firmAllergan Pharmaceuticals Ireland Unlimited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Allergan Pharmaceuticals Ireland Unlimited?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Allergan Pharmaceuticals Ireland Unlimited?
Jie He, Kejun Cheng and Thuy T. Nguyen are named on this Form 483, for the inspection of Jan 23 – Jan 30, 2025. Each investigator has a profile showing what they cite most.
When was Allergan Pharmaceuticals Ireland Unlimited inspected by FDA?
The inspection ran Jan 23 – Jan 30, 2025, and the Form 483 is dated January 30, 2025.
How do I get the full Form 483 for Allergan Pharmaceuticals Ireland Unlimited?
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.