FDA Inspection
Elekta IncElekta Inc – FDA Inspection, Jun 17, 2011
Record Details
This FDA Inspection record concerns Elekta Inc, with an inspection on June 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elekta Inc
- Inspection Date
- June 17, 2011
- Product Type
- Devices
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ID · 4b1e5f02-757a-466f-bbbd-007be20107aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730299
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(d)Design output - review and approval
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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 |
| February 10, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2015 | 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 1003704 - 2017-02-10
- FDA Inspection 955076 - 2015-12-16
- FDA Inspection 665312 - 2010-05-14
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