Home / Import refusals / AEK-2763966-2/11/1

FDA Import Refusal AEK-2763966-2/11/1 — Penumbra Inc.

Penumbra Inc. — FEI 3005168196

The FDA refused shipment AEK-2763966-2/11/1 from Penumbra Inc. (United States) on November 28, 2016. The refused product falls under Devices — CATHETER, PERCUTANEOUS. Cited charges: 118,341 This firm has 1 other import refusal on record.

Refusal Details

Date
November 28, 2016
Country
United States
Product Category
Devices
Product Code
74DQY CATHETER, PERCUTANEOUS
Charges
118,341

Recent inspections

  • 1145527 (NAI Mon Jun 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002192 (NAI Mon Feb 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965001 (VAI Tue Feb 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936229 (NAI Tue Aug 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938074 (VAI Wed Jul 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-2887666-3/11/1 (Tue Feb 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources