FDA inspection

RTI Surgical, Inc. dba RTI Biologics, Inc.: FDA inspection ending Apr 28, 2017

FDA inspection 1012915 · Alachua, FL

Key facts

Inspection ID 1012915
Firm RTI Surgical, Inc. dba RTI Biologics, Inc.
FEI number 3002719998
Address 11621 Research Cir
City Alachua
State FL
ZIP 32615-6825
Fiscal year 2017
Inspection end date Apr 28, 2017
Project area Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies
Product type Biologics, Drugs
Warning letter 525318

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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