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 3004810250.
Observations7
Issue DateOctober 22, 2019
StatusNo Warning Letter
Related Inspections5
Establishment Details
Firm
Otsuka Pharmaceutical Co., Ltd.
Location
Naka-Gun, -, Japan
FEI Number
3004810250
Product Type
Drugs
Issue Date
October 22, 2019
Country
Japan
Inspection History, 2012 to 2025
NAI1
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist