RTI Surgical, Inc. dba RTI Biologics, Inc. – FDA 483, Jan 30, 2026

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.