Orca1

FDA inspection

Gyrus ACMI, Inc.: FDA inspection ending May 23, 2018

FDA inspection 1055329 · No Action Indicated (NAI) · Redmond, Washington

Key facts

Inspection ID 1055329
Firm Gyrus ACMI, Inc.
FEI number 3004450998
Address 6675 185th Ave Ne
City Redmond
State Washington
ZIP 98052
Fiscal year 2018
Inspection end date May 23, 2018
Classification No Action Indicated (NAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None 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.

Other inspections at this establishment

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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