483
IsoTis OrthoBiologics, Inc.FDA 483 - IsoTis OrthoBiologics, Inc. - March 06, 2026
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Record Details
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.
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ID · ba2d0b4c-4133-420a-bac9-4bcbdcf44623