FDA inspection

Bionix, Llc: FDA inspection ending Jul 14, 2026

FDA inspection 1326218 · Voluntary Action Indicated (VAI) · Maumee, OH

Key facts

Inspection ID 1326218
Firm Bionix, Llc
FEI number 1526854
City Maumee
State OH
ZIP 43537
Country United States
Fiscal year 2026
Inspection end date Jul 14, 2026
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

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