FDA 483 - IsoTis OrthoBiologics, Inc. - March 06, 2026

IsoTis OrthoBiologics, Inc. in Irvine, CA, an HCT/P processor and distributor, received a Form 483 with two observations. The inspection revealed failures to ensure contract establishments complied with applicable CGTP requirements, specifically regarding consignee registration and maintenance of HCT/P storage temperature records. Additionally, the firm failed to inform consignees in writing about HCT/P tracking system requirements.