RTI Surgical, Inc. dba RTI Biologics, Inc.January 30, 2026

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

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Record Details

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.

Company: RTI Surgical, Inc. dba RTI Biologics, Inc.
Inspection Date: January 30, 2026
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
People: Mizanne E. Lewis (investigator)
Steen N. Graham

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ID · 98f0041d-36e5-4fea-b3a2-8a4e6208a933