FDA Inspection
Viewray, Inc.Viewray, Inc. – FDA Inspection, Dec 16, 2021
Record Details
This FDA Inspection record concerns Viewray, Inc., with an inspection on December 16, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Viewray, Inc.
- Inspection Date
- December 16, 2021
- Product Type
- Devices
View Company Profile
ID · be9ff34c-464d-4679-b221-fbd700837359
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158916
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design validation - production units
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