Endotec, Inc. – FDA Inspection, Sep 7, 2011

Record Details

This FDA Inspection record concerns Endotec, Inc., with an inspection on September 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Endotec, Inc.
Inspection Date: September 7, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f63f2b2b-944d-446c-aa6c-03acb229f732

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 743659
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.30(g)Design validation- Lack of or inadequate 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 820.250(b)Sampling methods - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures, Lack of or inadequate 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
January 19, 2011	OAI	Center for Devices and Radiological Health	Compliance: Devices
May 29, 2009	OAI	Center for Devices and Radiological Health	Compliance: Devices