FDA inspection

Woodway USA Inc: FDA inspection ending Aug 7, 2020

FDA inspection 1135513 · Voluntary Action Indicated (VAI) · Waukesha, WI

Key facts

Inspection ID 1135513
Firm Woodway USA Inc
FEI number 3000210901
Address W234n700 Busse Rd
City Waukesha
State WI
ZIP 53188-1750
Fiscal year 2020
Inspection end date Aug 7, 2020
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None 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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