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FDA Import Refusal 799-5256404-6/11/1 — Ambu Sdn. Bhd.

Ambu Sdn. Bhd. — FEI 3004040397

The FDA refused shipment 799-5256404-6/11/1 from Ambu Sdn. Bhd. (Malaysia) on January 22, 2025. The refused product falls under Devices — TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR). Cited charges: 118,341,508 This firm has 1 other import refusal on record.

Refusal Details

Date
January 22, 2025
Country
Malaysia
Product Category
Devices
Product Code
73CBI TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Charges
118,341,508

Recent inspections

  • 967208 (VAI Fri Apr 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853156 (VAI Thu Sep 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-5966306-4/21/1 (Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources