Gunnell Llc – FDA Inspection, Jun 30, 2010

Record Details

This FDA Inspection record concerns Gunnell Llc, with an inspection on June 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Gunnell Llc
Inspection Date: June 30, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 6ad0a878-76ed-4502-8145-64aa9441b22a

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 670779
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.25(b)Training records
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audits - defined intervals

Showing 10 of 11 citations.

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Other FDA inspections of Gunnell Llc

Date	Classification	Office	Project area
February 18, 2016	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 24, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 23, 2011	VAI	Center for Devices and Radiological Health	Compliance: Devices