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FDA Import Refusal 9KK-3405916-7/11/1 — Lepu Medical Technology (Beijing) Co., Ltd.

Lepu Medical Technology (Beijing) Co., Ltd. — FEI 3008002401

The FDA refused shipment 9KK-3405916-7/11/1 from Lepu Medical Technology (Beijing) Co., Ltd. (China) on October 16, 2020. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charges: 118,118,3280,3280,341,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 16, 2020
Country
China
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
118,118,3280,3280,341,341

Recent inspections

  • 1309170 (NAI Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1224751 (VAI Thu Nov 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915643 (VAI Thu Feb 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-7302828-4/11/1 (Tue Mar 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6823350-0/11/1 (Thu Sep 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8046095-8/11/1 (Wed Aug 26 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8002996-9/11/1 (Tue Aug 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-7670252-8/11/1 (Fri Aug 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources