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ISOTIS ORTHOBIOLOGICS, INC — FDA Facility Profile

FEI 3001503333

ISOTIS ORTHOBIOLOGICS, INC is an FDA-registered facility (FEI 3001503333) located in IRVINE, CA, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

Facility Details

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

Recent inspections

  • 1290380 (OAI Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1033932 (NAI Wed Nov 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942796 (NAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777655 (NAI Fri Apr 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-7670234-5/1/1 (Tue Nov 27 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-7686345-1/1/1 (Tue Nov 27 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 310-9100367-8/1/1 (Mon May 19 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources