FDA Inspection 922290 — Fuji Systems Corporation

Fuji Systems Corporation — FEI 3000308637

The FDA completed an inspection of Fuji Systems Corporation on Mar 27, 2015 in Nishishirakawa-Gun. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Mar 27, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Nishishirakawa-Gun (Japan)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures