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483
•IsoTis OrthoBiologics, Inc.•March 6, 2026

IsoTis OrthoBiologics, Inc. – FDA 483, Mar 6, 2026

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.

Company
IsoTis OrthoBiologics, Inc.
Inspection date
March 6, 2026
Product type
biologics
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Melsomar R. Ramos
View Company Profile

ID · ba2d0b4c-4133-420a-bac9-4bcbdcf44623

Violation Codes3
21 CFR 1271.l0(a)FD&C Act 704(b)21 U.S.C. 374(b)

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