FDA Inspection
GE Healthcare ASGE Healthcare AS – FDA Inspection, Apr 23, 2024
Record Details
This FDA Inspection record concerns GE Healthcare AS, with an inspection on April 23, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 957ef9cd-70fb-4579-a3f4-24bfef801923
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236691
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GE Healthcare AS
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 12, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GE Healthcare AS
- FDA Inspection 1100537 - 2019-08-27
- FDA Inspection 1037481 - 2017-11-10
- FDA Inspection 959608 - 2016-02-12
- FDA Inspection 915526 - 2015-02-03
- FDA Inspection 810910 - 2012-12-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.