Company
NorwayGE Healthcare AS, Oslo, Norway – FDA Inspections
Inspection records and compliance data for GE Healthcare AS in Oslo. 8 FDA inspections on record, 2 Form 483s, last inspected April 23, 2024.
Company Profile
This profile covers GE Healthcare AS based in Oslo, Norway.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 6
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected July 9, 2009. Last inspected April 23, 2024.
Most cited issue areas
- Ensuring compliance with plan and protocol1 inspection
- Environmental Monitoring System1 inspection
- Equipment Design, Size and Location1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 23, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1236691 |
| August 27, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1100537 |
| November 10, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1037481 |
| February 12, 2016 | NAI | Human Drugs · Drug Quality Assurance | 959608 |
| February 3, 2015 | NAI | Human Drugs · Drug Quality Assurance | 915526 |
| December 13, 2012 | VAI | Human Drugs · Drug Quality Assurance | 810910 |
| July 17, 2009 | VAI | Human Drugs · Bioresearch Monitoring | 605126 |
| July 9, 2009 | VAI | Human Drugs · Drug Quality Assurance | 601116 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GE Healthcare AS
FEI Number
3002807779
Address
Nycoveien 1, Oslo, Norway
Country
Norway
ID: 1b18a0cb-bd39-4d75-b4c3-3540b36621e0