Philips Medical Systems (Cleveland) Inc – FDA Inspection, Oct 30, 2008

Record Details

This FDA Inspection record concerns Philips Medical Systems (Cleveland) Inc, with an inspection on October 30, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company: Philips Medical Systems (Cleveland) Inc
Inspection Date: October 30, 2008
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · bbf3025a-5bdf-4316-8789-8b610af09f66

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 536918
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 806.20(b)(4)Justification for not reporting
21 CFR 820.198(a)(1)Uniform and timely processing
21 CFR 820.100(b)Documentation
21 CFR 820.30(b)Design plans- updated
21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.181(b)DMR production process specifications

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Philips Medical Systems (Cleveland) Inc

Date	Classification	Office	Project area
January 16, 2025	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
November 26, 2019	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 4, 2019	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
October 24, 2018	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 18, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices