Fournier Laboratories Ireland Limited
Form 483 issued September 12, 2023 · CARRIGTWOHILL, Ireland
- Observations
- 3
- Pages
- 1
- FEI number
- 3004134577
In short: On September 12, 2023, FDA issued a Form 483 with 3 observations to Fournier Laboratories Ireland Limited in CARRIGTWOHILL, Ireland (FEI 3004134577). Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.110 (1×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In-process testing during) IS…
- 02
The cleaning and disinfecting of the production rooms in…
- 03
release testing are not performed…
This inspection in context
Questions about this 483
What did FDA find at Fournier Laboratories Ireland Limited?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
When was Fournier Laboratories Ireland Limited inspected by FDA?
This Form 483 is dated September 12, 2023.
How do I get the full Form 483 for Fournier Laboratories Ireland Limited?
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.