FDA inspection

Ascensia Diabetes Care U.S. Inc.: FDA inspection ending Jan 10, 2017

FDA inspection 997724 · Voluntary Action Indicated (VAI) · Mishawaka, IN

Key facts

Inspection ID 997724
Firm Ascensia Diabetes Care U.S. Inc.
FEI number 1826988
Address 430 S Beiger St
City Mishawaka
State IN
ZIP 46544
Country United States
Fiscal year 2017
Inspection end date Jan 10, 2017
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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
  • 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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