FDA Inspection
Varex Imaging CorporationVarex Imaging Corporation – FDA Inspection, Apr 27, 2017
Record Details
This FDA Inspection record concerns Varex Imaging Corporation, with an inspection on April 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Todd Q. Dang (Issuing Officer)
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ID · b4704d09-0bcb-469c-91a9-e628135ce312
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012896
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Varex Imaging Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Varex Imaging Corporation
- FDA Inspection 664190 - 2010-05-19
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