Penumbra Inc. – FDA Inspection, Aug 28, 2009

Record Details

This FDA Inspection record concerns Penumbra Inc., with an inspection on August 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Penumbra Inc.
Inspection Date: August 28, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 0eb85d66-83fd-4f57-8ac0-e84940f07d44

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 614070
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(a)General
21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
21 CFR 820.20Management responsibility
21 CFR 820.100(a)(3)Identification of actions needed
21 CFR 820.140Lack of or inadequate procedures for handling
21 CFR 803.17Lack of Written MDR Procedures

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Other FDA inspections of Penumbra Inc.

Date	Classification	Office	Project area
June 21, 2021	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 13, 2018	Not classified	San Francisco District Office
February 13, 2017	NAI	Center for Devices and Radiological Health	Bioresearch Monitoring
February 23, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 4, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices