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Warning Letter

Case 543924 — FEI 3002807424

Facility

Recent inspections

  • 1253956 (NAI Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168226 (OAI Fri Apr 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111871 (OAI Fri Nov 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031649 (OAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873726 (NAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
Kyowa Hakko Bio Co., Ltd.
Date
August 10, 2018
Fiscal Year
2018
Product Type
Drugs
Center
CDER
Location
Hofu (Japan)