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FDA Import Refusal N56-0027354-8/12/1 — Dongguan Sure On Plastic & Fiber Products Co., LTD.

Dongguan Sure On Plastic & Fiber Products Co., LTD. — FEI 3003191210

The FDA refused shipment N56-0027354-8/12/1 from Dongguan Sure On Plastic & Fiber Products Co., LTD. (China) on August 14, 2020. The refused product falls under Devices — FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE. Cited charges: 223,3260,508

Refusal Details

Date
August 14, 2020
Country
China
Product Category
Devices
Product Code
80QKR FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
Charges
223,3260,508

Recent inspections

  • 1225545 (NAI Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113419 (NAI Wed Oct 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013734 (NAI Fri May 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890836 (NAI Thu Jul 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786437 (OAI Thu May 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

FDA data resources