Suppliers / GE HealthCare, Ireland

GE HealthCare, Ireland

Ireland 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for GE HealthCare, Ireland. The fuller profile, with 13 active US DMFs and 4 valid CEPs, is at GE Healthcare. Figures on this page cover only this record.

GE HealthCare, Ireland is a finished-dose manufacturer based in Ireland. It appears in 8 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with NAFDAC (NG), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by NAFDAC (NG), MFDS (Korea) and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 5 November 2021 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
8
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
EU GMP
1 of 1 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

  • 5 November 2021 VAI US FDA
  • 16 July 2018 NAI US FDA
  • 28 June 2016 NAI US FDA
  • 15 September 2014 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
CORK, United Arab Emirates Not on file
CORK, Ireland Not on file
Ireland, Ireland 3003579953
Co. Cork, Ireland Not on file
T45 AV60, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NAFDAC (NG) 3 2
ARCSA (EC) 3 None
MINSA (CR) 2 None
MFDS (Korea) None 2
ANVISA (Brazil) None 1
EMA None 1

Questions about GE HealthCare, Ireland

Does GE HealthCare, Ireland hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for GE HealthCare, Ireland. It does have 8 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is GE HealthCare, Ireland FDA-registered?
One site operated by GE HealthCare, Ireland carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did GE HealthCare, Ireland's last inspection go?
The most recent inspection on record closed on 5 November 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does GE HealthCare, Ireland manufacture?
5 registered sites are on record, in United Arab Emirates, Ireland and Nigeria (Cork, Ireland and Co. Cork among others). Every site is listed on this page with the register it came from.
Which regulators recognise GE HealthCare, Ireland's GMP?
Current GMP certificates are on record from NAFDAC (NG), MFDS (Korea), ANVISA (Brazil) and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 5 November 2021.

Comparable suppliers

Abbvie Ireland Nl also in Ireland Amgen Technology (Ireland) Unlimited also in Ireland Chanelle Pharmaceuticals Manufacturing also in Ireland Fournier Laboratories Ireland also in Ireland Haleon Ireland Dungarvan also in Ireland

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates