LEO Laboratories Ltd.
Form 483 issued June 24, 2022 · Crumlin, Ireland
- Inspection
- Jun 20 – Jun 24, 2022
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807468
In short: On June 24, 2022, FDA issued a Form 483 with 2 observations to LEO Laboratories Ltd. in Crumlin, Dublin (FEI 3002807468) after an inspection that ran Jun 20 – Jun 24, 2022. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.46(b) (1×) · 211.48(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over air pressure and dust is not provided when appropriate for the…
- 02
The plumbing system contains defects that could contribute to the…
This inspection in context
Questions about this 483
What did FDA find at LEO Laboratories Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
When was LEO Laboratories Ltd. inspected by FDA?
The inspection ran Jun 20 – Jun 24, 2022, and the Form 483 is dated June 24, 2022.
How do I get the full Form 483 for LEO Laboratories Ltd.?
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.