FDA Inspection
Elekta IncElekta Inc – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Elekta Inc, with an inspection on February 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e30dc953-f799-4178-a9b4-f8a3327e2101
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003704
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.200(b)Analyzing service report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elekta Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elekta Inc
- FDA Inspection 1190646 - 2022-09-16
- FDA Inspection 955076 - 2015-12-16
- FDA Inspection 730299 - 2011-06-17
- FDA Inspection 665312 - 2010-05-14
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.