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Import refusals
/ AEK-7670234-5/1/1
AEK-7670234-5/1/1
IsoTis OrthoBiologics, Inc. — FEI 3001503333
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))
Compliance actions
Warning Letter (723370)
(Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
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)
Refusal Details
Date
November 27, 2007
Country
United States
Product Category
Devices
Product Code
89NEN FILLER RECOMB HUMAN BONE MORPHOGENETIC PROTEIN COLLAGEN SCAFFOLD W ALLOGRAFT BONE DOWEL, OSTEIONDUCT
Charges
118