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Hubei Gedian Humanwell Pharmaceutical Co., Ltd — FDA Facility Profile

FEI 3004117486

Hubei Gedian Humanwell Pharmaceutical Co., Ltd is an FDA-registered facility (FEI 3004117486) located in Hubei 436070, CN. Registered operations: API MANUFACTURE. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Hubei 436070 (CN)
Registration Expires
December 31, 2026
Operations
API MANUFACTURE
Source
decrs

Recent inspections

  • 1295344 (OAI Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098272 (VAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 971471 (VAI Fri May 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854699 (VAI Thu Oct 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 799-3939292-5/21/1 (Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3766501-7/21/1 (Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3812934-4/21/1 (Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0799565-5/11/1 (Mon Jun 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-3164575-4/11/1 (Tue May 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 065-3930610-7/1/1 (Mon Mar 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 799-2479697-7/1/1 (Fri Oct 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 065-3711310-9/1/1 (Fri Apr 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 065-3711450-3/1/1 (Wed Apr 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources