GeoTec, Inc. – FDA Inspection, Aug 19, 2016

Record Details

This FDA Inspection record concerns GeoTec, Inc., with an inspection on August 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: GeoTec, Inc.
Inspection Date: August 19, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · fa49e15b-83e4-4440-8b03-12f70d3dca3c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 983089
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.25(a)Personnel
21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(i)Software validation for automated processes

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Other FDA inspections of GeoTec, Inc.

Date	Classification	Office	Project area
September 29, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 24, 2015	OAI	Center for Devices and Radiological Health	Compliance: Devices
December 21, 2011	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 8, 2010	NAI	Center for Devices and Radiological Health	Compliance: Devices