GE Healthcare AS avd Lindesnes
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Norway
- Registered address
- Lindesnesveien 208, Lindesnes, NO-4521, Norway (NOR)
- Operations here
- analysisapi manufacturepack
- FDA identifiers
- FEI 3002807778 · DUNS 518890970
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-02-07
- NAIDrug Quality Assurance2017-12-22
Drugs this plant is listed as making
3 distinct drugs across 9 products name this site in their FDA label.
- gadodiamideGE Healthcare Inc.
- gadoterate meglumineGE Healthcare
- IohexolGE Healthcare Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.