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 3008185830.
Observations6
Issue DateApril 21, 2015
Status1 Related Warning Letter
Related Inspections2
Establishment Details
Firm
Hoya Corporation - Pentax Life Division
Location
Akishima, -, Japan
FEI Number
3008185830
Product Type
Devices
Issue Date
April 21, 2015
Country
Japan
Inspection History, 2014 to 2015
NAI1
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.