North Coast Medical Inc – FDA Inspection, May 25, 2011

Record Details

This FDA Inspection record concerns North Coast Medical Inc, with an inspection on May 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: North Coast Medical Inc
Inspection Date: May 25, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 78eb4cac-356b-4923-be1b-ed2f956f4152

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 727010
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 820.40Procedures not adequately established or maintained
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.180(b)Retention period
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 820.30(g)Design validation - simulated testing

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Other FDA inspections of North Coast Medical Inc

Date	Classification	Office	Project area
August 2, 2024	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 28, 2023	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 30, 2016	Not classified	San Francisco District Office	Postmarket Assurance: Devices
April 24, 2012	NAI	Center for Devices and Radiological Health	Compliance: Devices
February 24, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices