Gyrus ACMI, Inc., Redmond, WA – FDA Inspections

Inspection records and compliance data for Gyrus ACMI, Inc. in Redmond, Washington. 6 FDA inspections on record, 1 Form 483, last inspected May 23, 2018.

Company Profile

This profile covers Gyrus ACMI, Inc. based in Redmond, Washington, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 3
NAI: 3
Form 483s: 1
Warning letters: 0

First inspected June 13, 2011. Last inspected May 23, 2018.

Most cited issue areas

Sponsors" general responsibilities2 inspections
No investigator agreement1 inspection
Sponsors' general responsibilities1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
May 23, 2018	NAI	Medical Devices & Rad Health · Compliance: Devices	1055329
April 17, 2018	VAI	Medical Devices & Rad Health · Project Evaluation: Devices	1048537
April 3, 2015	VAI	Medical Devices & Rad Health · Compliance: Devices	920803
June 21, 2013	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	840684
June 14, 2012	VAI	Medical Devices & Rad Health · Bioresearch Monitoring	789809
June 13, 2011	NAI	Medical Devices & Rad Health · Compliance: Devices	731008

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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