Natus Medical Incorporated, Seattle, WA – FDA Inspections

Inspection records and compliance data for Natus Medical Incorporated in Seattle, Washington. 10 FDA inspections on record (1 OAI), 2 Form 483s, last inspected October 05, 2018.

Company Profile

This profile covers Natus Medical Incorporated based in Seattle, Washington, United States.

FDA Inspection History

FDA inspections: 10
OAI: 1
VAI: 4
NAI: 4
Unclassified: 1
Form 483s: 2
Warning letters: 0

First inspected October 8, 2008. Last inspected October 5, 2018.

Most cited issue areas

Nonconforming product, Lack of or inadequate procedures2 inspections
Acceptance records1 inspection
Calibration documentation1 inspection

FDA inspections (10)

Date	Result	FDA center(s)	Insp. #
October 5, 2018	Not classified	Medical Devices & Rad Health	1122379
August 13, 2018	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1062328
June 27, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1017171
July 27, 2016	VAI	Medical Devices & Rad Health · Compliance: Devices	982062
September 10, 2014	OAI	Medical Devices & Rad Health · Compliance: Devices	898177
July 11, 2012	NAI	Medical Devices & Rad Health · Compliance: Devices	791200
February 7, 2012	VAI	Medical Devices & Rad Health · Compliance: Devices	769486
September 2, 2010	NAI	Medical Devices & Rad Health · Compliance: Devices	680341
June 9, 2009	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	589485
October 8, 2008	VAI	Medical Devices & Rad Health · Compliance: Devices	542580

FDA documents

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

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