FDA inspection

Avalign Instruments & Implants: FDA inspection ending Jan 16, 2025

FDA inspection 1251833 · Voluntary Action Indicated (VAI) · Fort Wayne, IN

Key facts

Inspection ID 1251833
Firm Avalign Instruments & Implants
FEI number 3006128100
Address 8727 Clinton Park Dr
City Fort Wayne
State IN
ZIP 46825
Country United States
Fiscal year 2025
Inspection end date Jan 16, 2025
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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

Browse all FDA inspections