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FDA Import Refusal AEK-3164575-4/11/1 — Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

Hubei Gedian Humanwell Pharmaceutical Co., Ltd. — FEI 3004117486

The FDA refused shipment AEK-3164575-4/11/1 from Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (China) on May 16, 2017. The refused product falls under Drugs and Biologics — PROGESTERONE (PROGESTIN). Cited charge: 3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 16, 2017
Country
China
Product Category
Drugs and Biologics
Product Code
65JCC31 PROGESTERONE (PROGESTIN)
Charges
3280

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

Other 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)
  • 065-3930610-7/1/1 (Mon Mar 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources