Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002808005.
Observations8
Issue DateJanuary 30, 2025
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Riken Keiki Co., Ltd.
Location
Kasukabe, Japan
FEI Number
3002808005
Product Type
Devices
Issue Date
January 30, 2025
Country
Japan
Inspection History, 2015 to 2025
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.