Spacelabs Healthcare, Inc. – FDA Inspection, Mar 12, 2010

Record Details

This FDA Inspection record concerns Spacelabs Healthcare, Inc., with an inspection on March 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Spacelabs Healthcare, Inc.
Inspection Date: March 12, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a4dfc61d-1db0-4e6e-b85f-248a16dc1faa

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 652281
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.30(f)Design verification acceptance criteria
21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
21 CFR 820.100(b)Documentation
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.100(a)(3)Identification of actions needed
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.198(e)(6)Results of investigation
21 CFR 820.200(d)(6)Test and inspection data

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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