Endotec, Inc. – FDA Inspection, May 29, 2009

Record Details

This FDA Inspection record concerns Endotec, Inc., with an inspection on May 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Endotec, Inc.
Inspection Date: May 29, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 3d416002-c78e-4ed0-bddf-ef54905dc529

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 585102
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.100(a)(2)Investigation
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.70(a)(5)Criteria for workmanship
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures

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Other FDA inspections of Endotec, Inc.

Date	Classification	Office	Project area
December 19, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices
October 14, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 7, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 19, 2011	OAI	Center for Devices and Radiological Health	Compliance: Devices