Fournier Laboratories Ireland
Ireland 3 duplicate records merged Updated 9 July 2026
Fournier Laboratories Ireland is a finished-dose manufacturer based in Ireland. It appears in 5 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), EMA and INVIMA (CO). Its GMP standing is certified by MFDS (Korea), EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 25 November 2022 as VAI.
2
registered plants
1 with an FDA FEI number
5
filings
across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 25 November 2022 VAI US FDA
- 23 November 2018 VAI US FDA
- 14 December 2017 NAI US FDA
- 26 September 2014 VAI US FDA
- 20 October 2011 NAI US FDA
- 6 March 2009 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| CORK, Ireland | Not on file |
| Ireland, Ireland | 3004134577 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 3 | None |
| EMA | 1 | 2 |
| INVIMA (CO) | 1 | None |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 25 November 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates