Amplion Clinical Communications, Inc. – FDA Inspection, Nov 4, 2013

Record Details

This FDA Inspection record concerns Amplion Clinical Communications, Inc., with an inspection on November 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: Amplion Clinical Communications, Inc.
Inspection Date: November 4, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 8e29d9ee-10bc-4205-99ae-ff36b8c74aa7

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 854307
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

Showing 10 of 12 citations.

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Other FDA inspections of Amplion Clinical Communications, Inc.

Date	Classification	Office	Project area
February 16, 2023	NAI	Center for Devices and Radiological Health	Compliance: Devices
September 8, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 4, 2019	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 7, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 5, 2014	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices