Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3001503333.
Observations3
Issue DateOctober 17, 2025
Status1 Related Warning Letter
Related Inspections4
Establishment Details
Firm
IsoTis OrthoBiologics, Inc.
Location
Irvine, California
FEI Number
3001503333
Product Type
Devices
Issue Date
October 17, 2025
Country
United States
Inspection History, 2012 to 2025
NAI3
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.
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