FDA inspection

Nikomed USA, Inc: FDA inspection ending Feb 6, 2017

FDA inspection 1000189 · Voluntary Action Indicated (VAI) · Hatboro, PA

Key facts

Inspection ID 1000189
Firm Nikomed USA, Inc
FEI number 2245574
Address 2800 Turnpike Dr Ste 1
City Hatboro
State PA
ZIP 19040
Country United States
Fiscal year 2017
Inspection end date Feb 6, 2017
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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