Home / Import refusals / EFJ-0001823-5/11/1

FDA Import Refusal EFJ-0001823-5/11/1 — Philosys Co. Ltd

Philosys Co. Ltd — FEI 3010172486

The FDA refused shipment EFJ-0001823-5/11/1 from Philosys Co. Ltd (South Korea) on March 30, 2021. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charge: 508 This firm has 4 other import refusals on record.

Refusal Details

Date
March 30, 2021
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
508

Recent inspections

  • 1201165 (OAI Thu Mar 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063811 (VAI Thu Aug 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-6922980-5/11/1 (Wed Feb 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EFJ-0001823-5/21/1 (Tue Mar 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-4484749-1/11/1 (Tue Mar 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-4484749-1/21/1 (Tue Mar 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources