FDA Inspection
GE OEC Medical Systems, IncGE OEC Medical Systems, Inc – FDA Inspection, Nov 21, 2008
Record Details
This FDA Inspection record concerns GE OEC Medical Systems, Inc, with an inspection on November 21, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GE OEC Medical Systems, Inc
- Inspection Date
- November 21, 2008
- Product Type
- Devices
View Company Profile
ID · 4e159aea-7986-478b-88b6-a8a410d9579e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 550334
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.18(e)MDR not evaluated per 820.198
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.180Storage
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GE OEC Medical Systems, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 29, 2021 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 22, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 25, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 28, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for GE OEC Medical Systems, Inc
- FDA Inspection 1217708 - 2023-08-17
- FDA Inspection 1145789 - 2021-06-29
- FDA Inspection 1056985 - 2018-06-22
- FDA Inspection 920992 - 2015-03-25
- FDA Inspection 747277 - 2011-09-28
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.