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PENUMBRA, INC. — FDA Facility Profile

FEI 3005168196

PENUMBRA, INC. is an FDA-registered facility (FEI 3005168196) located in Alameda, CA, US. RegDataLab tracks 10 or more FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Alameda, CA (US)
Registration Expires
N/A
Operations
Source
device

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))
  • 876601 (NAI Wed Apr 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769596 (NAI Mon Feb 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 676922 (VAI Tue Aug 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 614070 (OAI Fri Aug 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 578236 (NAI Thu Feb 26 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 799-2887666-3/11/1 (Tue Feb 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-2763966-2/11/1 (Mon Nov 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources