# FDA 483 - RTI Surgical, Inc. dba RTI Biologics, Inc. - January 30, 2026

Source: https://www.keypedia.com/records/483/rti-surgical-inc-dba-rti-biologics-inc/98f0041d-36e5-4fea-b3a2-8a4e6208a933

> FDA 483 for RTI Surgical, Inc. dba RTI Biologics, Inc. on January 30, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RTI Surgical, Inc. dba RTI Biologics, Inc.
- Inspection Date: 2026-01-30
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: RTI Surgical, Inc. dba RTI Biologics, Inc. in Alachua, FL, a tissue manufacturer, was inspected regarding its HCT/P manufacturing processes and facility conditions. The inspection revealed deviations from standard operating procedures during tissue processing and donor tissue reconciliation, as well as congested facility conditions that could impede the prevention of communicable disease spread. These issues indicate a lack of adherence to established procedures and proper facility maintenance.

## Related Documents

- [483 - 2012-07-11](https://www.keypedia.com/records/483/rti-surgical-inc-dba-rti-biologics-inc/ce391437-3550-4865-9ed2-5ec6976b5be9)
- [WARNING_LETTER - 2012-07-11](https://www.keypedia.com/records/warning_letter/rti-surgical-inc-dba-rti-biologics-inc/b5ad1ca5-1df5-4296-8e71-6e81d6e6e5c8)
- [WARNING_LETTER - 2017-04-28](https://www.keypedia.com/records/warning_letter/rti-surgical-inc-dba-rti-biologics-inc/2845f3aa-9679-4f58-95f3-6754d8531bea)

## Related Officers

- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)
- [Steen N. Graham](https://www.keypedia.com/people/steen-n-graham/e0ce4c37-b1f1-4d94-8071-2d89b74975fd)

Company: https://www.keypedia.com/companies/rti-surgical-inc-dba-rti-biologics-inc/ab757bb1-704a-479f-81c8-259248ec1a38

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6