FDA Inspection 925884 — Aizu Olympus Co., Ltd.

Aizu Olympus Co., Ltd. — FEI 3002964398

The FDA completed an inspection of Aizu Olympus Co., Ltd. on April 17, 2015 in Aizuwakamatsu. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 17, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Aizuwakamatsu (Japan)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
369621 CFR 820.100(b)Documentation