FDA inspection

Nuwellis Inc: FDA inspection ending Dec 6, 2016

FDA inspection 1005020 · No Action Indicated (NAI) · Eden Prairie, MN

Key facts

Inspection ID 1005020
Firm Nuwellis Inc
FEI number 3007137787
Address 12988 Valley View Rd
City Eden Prairie
State MN
ZIP 55344
Country United States
Fiscal year 2017
Inspection end date Dec 6, 2016
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No 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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