FDA Inspection
Elekta, Inc.Elekta, Inc. – FDA Inspection, Nov 21, 2011
Record Details
This FDA Inspection record concerns Elekta, Inc., with an inspection on November 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elekta, Inc.
- Inspection Date
- November 21, 2011
- Product Type
- Devices
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ID · 4b3b104d-bae3-4511-b7db-9bd084eebf41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753194
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Elekta, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 28, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elekta, Inc.
- FDA Inspection 940239 - 2015-08-26
- FDA Inspection 616125 - 2009-09-28
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