FDA Inspection 789262 — Accuray Incorporated

Accuray Incorporated — FEI 1000123585

The FDA completed an inspection of Accuray Incorporated on Jul 3, 2012 in Sunnyvale, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jul 3, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Sunnyvale, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.