FDA inspection

BAXALTA US INC.: FDA inspection ending Nov 26, 2025

FDA inspection 1293098 · Voluntary Action Indicated (VAI) · Round Lake, IL

Key facts

Inspection ID 1293098
Firm BAXALTA US INC.
FEI number 3012385969
Address 25212 W Il Route 120
City Round Lake
State IL
ZIP 60073
Country United States
Fiscal year 2026
Inspection end date Nov 26, 2025
Classification Voluntary Action Indicated (VAI)
Project area Blood and Blood Products
Product type Biologics

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 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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