Philips Respironics, Inc. – FDA Inspection, Jul 1, 2010

Record Details

This FDA Inspection record concerns Philips Respironics, Inc., with an inspection on July 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Philips Respironics, Inc.
Inspection Date: July 1, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 933f79ea-aa6c-486f-b1e4-9e25925b828d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 667581
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.150Lack of or inadequate procedures for storage.
21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 820.70(a)Production processes
21 CFR 820.20(e)Quality System Procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule

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Other FDA inspections of Philips Respironics, Inc.

Date	Classification	Office	Project area
May 19, 2022	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 9, 2021	OAI	Center for Devices and Radiological Health	Compliance: Devices
September 10, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 10, 2020	OAI	Center for Devices and Radiological Health	Compliance: Devices
May 21, 2018	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices