Home / Import refusals / 344-1004211-2/11/1

FDA Import Refusal 344-1004211-2/11/1 — Physio-Control, Inc.

Physio-Control, Inc. — FEI 3015876

The FDA refused shipment 344-1004211-2/11/1 from Physio-Control, Inc. (United States) on April 25, 2019. The refused product falls under Devices — AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE). Cited charge: 3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 25, 2019
Country
United States
Product Category
Devices
Product Code
74MKJ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Charges
3280

Recent inspections

  • 1230558 (NAI Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111211 (VAI Tue Nov 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086723 (NAI Fri Mar 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035043 (VAI Fri Dec 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994067 (VAI Fri Nov 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

  • Injunction (191) (Tue Nov 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-1110471-8/11/1 (Wed Mar 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0275225-1/11/1 (Mon Jan 04 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-8944786-7/11/1 (Mon Mar 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AA8-0025560-3/2/1 (Mon Sep 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • U16-5213146-1/1/1 (Fri Sep 21 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources