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Kyowa Hakko Bio Co., Ltd. — FDA Facility Profile

FEI 3002807424

Kyowa Hakko Bio Co., Ltd. is an FDA-registered facility (FEI 3002807424) located in Yamaguchi 747-8522, JP. Registered operations: API MANUFACTURE. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.

Facility Details

Location
Yamaguchi 747-8522 (JP)
Registration Expires
December 31, 2026
Operations
API MANUFACTURE
Source
decrs

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))
  • 753000 (VAI Thu Oct 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 672443 (OAI Fri Jun 25 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 314-0218386-2/12/1 (Mon Aug 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 314-0218105-6/12/1 (Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources