GE Healthcare AS
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
- Nycoveien 1, Oslo, NO-0485, Norway (NOR)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002807779 · DUNS 515048908
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-04-23
- VAIDrug Quality Assurance2019-08-27
- VAIDrug Quality Assurance2017-11-10
- NAIDrug Quality Assurance2016-02-12
- NAIDrug Quality Assurance2015-02-03
- VAIDrug Quality Assurance2012-12-13
- VAIBioresearch Monitoring2009-07-17
- VAIDrug Quality Assurance2009-07-09
Drugs this plant is listed as making
10 distinct drugs across 15 products name this site in their FDA label.
- Fluciclovine F-18Blue Earth Diagnostics
- Flutemetamol F-18GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
- gadodiamideGE Healthcare Inc.
- gadoterate meglumineGE Healthcare
- Human Albumin Microspheres and PerflutrenGE Healthcare Inc.
- IodixanolGE Healthcare Inc.
- IohexolGE Healthcare Inc.
- Technetium Tc-99m ExametazimeMedi-Physics Inc. dba GE Healthcare.
- Technetium Tc-99m Exametazime and Cobaltous ChlorideMedi-Physics, Inc. dba GE Healthcare
- TetrofosminMedi-Physics Inc. dba GE Healthcare
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.