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

Source: https://www.keypedia.com/records/483/isotis-orthobiologics-inc/ba2d0b4c-4133-420a-bac9-4bcbdcf44623

> FDA 483 for IsoTis OrthoBiologics, Inc. on March 06, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: IsoTis OrthoBiologics, Inc.
- Inspection Date: 2026-03-06
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2025-10-17](https://www.keypedia.com/records/warning_letter/isotis-orthobiologics-inc/916c2859-5b32-4196-8262-318254949828)
- [483 - 2026-03-06](https://www.keypedia.com/records/483/isotis-orthobiologics-inc/ded7ad85-8b9c-44e0-9843-7e371b7c3344)

## Related Officers

- [Melsomar R. Ramos](https://www.keypedia.com/people/melsomar-r-ramos/395e7ddc-ed98-455a-a143-0ee5f46804f4)

Company: https://www.keypedia.com/companies/isotis-orthobiologics-inc/df4a7da7-92c2-474d-b810-2ad643c54425

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6