Endotec, Inc. – FDA Inspection, Jan 19, 2011

Record Details

This FDA Inspection record concerns Endotec, Inc., with an inspection on January 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Endotec, Inc.
Inspection Date: January 19, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · ff176dd4-2fc6-441a-93b0-09bcd887d88c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 706996
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(c)Design input - Lack of or inadequate procedures
21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.150Lack of or inadequate procedures for storage.
21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 820.75(a)Documentation

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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
May 29, 2009	OAI	Center for Devices and Radiological Health	Compliance: Devices