FDA Inspection
Elekta, Inc.Elekta, Inc. – FDA Inspection, May 21, 2010
Record Details
This FDA Inspection record concerns Elekta, Inc., with an inspection on May 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elekta, Inc.
- Inspection Date
- May 21, 2010
- Product Type
- Devices
View Company Profile
ID · 955c7437-d252-480d-8606-374adc38d2de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 665439
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elekta, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elekta, Inc.
- FDA Inspection 1123129 - 2019-12-13
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