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

From March 2 to March 6, 2026, the FDA inspected IsoTis OrthoBiologics, Inc., a processor and distributor of human tissue products located in Irvine, California. The inspection revealed two primary regulatory violations involving the company’s oversight of its distribution network. First, IsoTis failed to ensure that its contract partners adhered to Good Tissue Practice standards. This included distributing human bone tissue to firms that were not properly registered with the FDA and failing to require these partners to maintain and review storage temperature records to ensure product integrity. Second, the company did not provide written notification to its partners regarding mandatory tracking requirements for human tissue products distributed between 2017 and 2026. These findings, issued under the Federal Food, Drug, and Cosmetic Act and specific human tissue regulations (21 CFR 1271), represent observations of non-compliance that the firm must address. Although this document is not a final agency determination, IsoTis OrthoBiologics, Inc. is expected to implement corrective actions or provide a formal response to the FDA detailing how they will resolve these oversight and tracking deficiencies to ensure the safe distribution of human bone tissue products.