Home / Import refusals / AEK-1104305-4/11/1

FDA Import Refusal AEK-1104305-4/11/1 — Oscor Inc.

Oscor Inc. — FEI 1035166

The FDA refused shipment AEK-1104305-4/11/1 from Oscor Inc. (United States) on May 13, 2022. The refused product falls under Devices — PULSE-GENERATOR, PACEMAKER, EXTERNAL. Cited charges: 118,3280,341,508 This firm has 3 other import refusals on record.

Refusal Details

Date
May 13, 2022
Country
United States
Product Category
Devices
Product Code
74DTE PULSE-GENERATOR, PACEMAKER, EXTERNAL
Charges
118,3280,341,508

Recent inspections

  • 1151577 (VAI Fri Sep 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009131 (VAI Thu Mar 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963563 (OAI Thu Mar 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 845108 (NAI Wed Aug 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790329 (NAI Tue Jun 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-2962187-8/21/1 (Wed Mar 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-2090800-7/1/1 (Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • DM4-0409089-4/1/1 (Fri Jul 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources