Home / Import refusals / 8UE-0027917-3/102/1

FDA Import Refusal 8UE-0027917-3/102/1 — Jiangsu Guangda Medical Material Group Co., Ltd.

Jiangsu Guangda Medical Material Group Co., Ltd. — FEI 3006847952

The FDA refused shipment 8UE-0027917-3/102/1 from Jiangsu Guangda Medical Material Group Co., Ltd. (China) on December 30, 2020. The refused product falls under Devices — FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE. Cited charges: 118,341,508

Refusal Details

Date
December 30, 2020
Country
China
Product Category
Devices
Product Code
80QKR FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
Charges
118,341,508

Recent inspections

  • 1217706 (VAI Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081397 (NAI Wed Dec 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 926501 (VAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802595 (VAI Wed Sep 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources