FDA inspection

Gyrus ACMI, Inc.: FDA inspection ending Apr 3, 2015

FDA inspection 920803 · Voluntary Action Indicated (VAI) · Redmond, WA

Key facts

Inspection ID 920803
Firm Gyrus ACMI, Inc.
FEI number 3004450998
Address 6675 185th Ave Ne
City Redmond
State WA
ZIP 98052
Country United States
Fiscal year 2015
Inspection end date Apr 3, 2015
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
  • Yes 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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