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FDA Import Refusal 799-1254343-3/11/1 — MANDELAY KFT

MANDELAY KFT — FEI 3010452718

The FDA refused shipment 799-1254343-3/11/1 from MANDELAY KFT (Hungary) on July 14, 2017. The refused product falls under Devices — DEVICE, BIOFEEDBACK. Cited charges: 118,3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 14, 2017
Country
Hungary
Product Category
Devices
Product Code
84HCC DEVICE, BIOFEEDBACK
Charges
118,3280,341

Recent inspections

  • 1106700 (OAI Thu Oct 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-6362654-3/11/2 (Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6362654-3/11/1 (Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7597039-0/11/1 (Thu Aug 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7597039-0/11/2 (Thu Aug 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-8702253-2/1/1 (Fri Aug 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources