FDA inspection

Splintek, Inc: FDA inspection ending Feb 5, 2016

FDA inspection 965812 · Voluntary Action Indicated (VAI) · Lenexa, KS

Key facts

Inspection ID 965812
Firm Splintek, Inc
FEI number 3003322666
Address 15555 W 108th St
City Lenexa
State KS
ZIP 66219
Country United States
Fiscal year 2016
Inspection end date Feb 5, 2016
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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