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Warning Letter

Case 723370 — FEI 3001503333

Facility

Recent inspections

  • 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))

Action Details

Facility
IsoTis OrthoBiologics, Inc.
Date
February 24, 2026
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
Irvine, CA (United States)