Apnea Sciences Corporation – FDA Inspection, Jan 28, 2014

Record Details

This FDA Inspection record concerns Apnea Sciences Corporation, with an inspection on January 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Apnea Sciences Corporation
Inspection Date: January 28, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · d8b4ff81-911f-4d7a-ae96-0097e395c28d

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 862347
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 803.52(c)(3)Manufacturer Name and Address
21 CFR 803.52(e)(1)Contact Office Name and Address
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.198(d)Evaluation, timeliness, identification
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.40(a)Document locations, Dissemination, etc.
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.100(a)Lack of or inadequate procedures

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Other FDA inspections of Apnea Sciences Corporation

Date	Classification	Office	Project area
September 18, 2024	NAI	Los Angeles District Office	Postmarket Assurance: Medical Devices
August 19, 2021	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
July 16, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices
November 12, 2015	OAI	Center for Devices and Radiological Health	Compliance: Devices
September 18, 2015	OAI	Center for Devices and Radiological Health	Compliance: Devices