Allergan Pharmaceuticals Ireland Unlimited
Form 483 issued December 17, 2019 · Westport, Ireland
- Inspection
- Dec 17, 2019
- Investigator
- Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 3002806285
In short: On December 17, 2019, FDA issued a Form 483 with 3 observations to Allergan Pharmaceuticals Ireland Unlimited in Westport, Ireland (FEI 3002806285) after an inspection that ran Dec 17, 2019. The investigator was Wayne Seifert. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your examination of samples did not assure that the drug…
- 02
On 12/09/2019, discoloration was observed on () 4) supporting the (>) (4) inside the Biologics®)@ You…
- 03
Equipment and utilities are not…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Pharmaceuticals Ireland Unlimited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Allergan Pharmaceuticals Ireland Unlimited?
Wayne Seifert is named on this Form 483, for the inspection of Dec 17, 2019. Each investigator has a profile showing what they cite most.
When was Allergan Pharmaceuticals Ireland Unlimited inspected by FDA?
The inspection ran Dec 17, 2019, and the Form 483 is dated December 17, 2019.
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.