Spacelabs Healthcare, Inc. – FDA Inspection, Apr 2, 2014

Record Details

This FDA Inspection record concerns Spacelabs Healthcare, Inc., with an inspection on April 2, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Spacelabs Healthcare, Inc.
Inspection Date: April 2, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 2a97441b-ffef-4317-b8e1-b8b6a4c846df

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 872781
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.30(g)Design validation acceptance criteria
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product control

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Other FDA inspections of Spacelabs Healthcare, Inc.

Date	Classification	Office	Project area
September 15, 2022	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 7, 2018	Not classified	Seattle District Office
June 1, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices
March 9, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
July 31, 2015	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices