Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-12.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Sep 2023 – 12 Sep 2023 | Human Drugs | 483 | On file |
| 11 Dec 2017 – 14 Dec 2017 | Human Drugs | Clean | |
| 7 Mar 2016 – 11 Mar 2016 | Human Drugs | Clean | |
| 22 Sep 2014 – 26 Sep 2014 | Human Drugs | 483 | On file |
| 20 Oct 2011 | Not recorded | Clean | |
| 6 Mar 2009 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Richard Ledwidge1 insp.
Kham Phommachanh1 insp.
Felix Maldonado1 insp.
James C Maclaughlin1 insp.
Simone E Pitts1 insp.
Anita R Michael1 insp.
Monica E Caphart1 insp.
Full site report
Get the verbatim findings behind Fournier Laboratories Ireland Limited's 2 Form 483s
The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat