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FDA Import Refusal 9RK-0223488-8/1/1 — Racer Technology Pte Ltd

Racer Technology Pte Ltd — FEI 3003202721

The FDA refused shipment 9RK-0223488-8/1/1 from Racer Technology Pte Ltd (Singapore) on December 30, 2016. The refused product falls under Devices — HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE). Cited charge: 118

Refusal Details

Date
December 30, 2016
Country
Singapore
Product Category
Devices
Product Code
73KFZ HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
Charges
118

Recent inspections

  • 920190 (NAI Tue Mar 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840299 (OAI Thu Jun 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 649047 (NAI Tue Feb 02 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

FDA data resources