Home / Import refusals / 799-9236757-1/11/1

FDA Import Refusal 799-9236757-1/11/1 — Heartsine Technologies Inc

Heartsine Technologies Inc — FEI 3004018643

The FDA refused shipment 799-9236757-1/11/1 from Heartsine Technologies Inc (United States) on November 6, 2020. The refused product falls under Devices — AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE). Cited charges: 118,476 This firm has 4 other import refusals on record.

Refusal Details

Date
November 6, 2020
Country
United States
Product Category
Devices
Product Code
74MKJ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Charges
118,476

Recent inspections

  • 1068673 (NAI Thu May 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897171 (VAI Tue Sep 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847671 (OAI Thu Aug 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 652945 (NAI Tue Mar 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 601913 (OAI Tue Aug 04 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-1969418-3/11/1 (Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9104243-3/11/1 (Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-6479709-7/11/1 (Wed Jul 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9536289-9/11/1 (Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources