Home / Compliance actions / 507037

Warning Letter

Case 507037 — FEI 3002806840

Facility

Recent inspections

  • 1297890 (VAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085997 (NAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025783 (NAI Thu Jul 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975168 (OAI Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754938 (NAI Thu Oct 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Sekisui Medical Co., Ltd.
Date
November 8, 2016
Fiscal Year
2017
Product Type
Drugs
Center
CDER
Location
Hachimantai (Japan)