North Coast Medical Inc – FDA Inspection, Feb 24, 2012

Record Details

This FDA Inspection record concerns North Coast Medical Inc, with an inspection on February 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: North Coast Medical Inc
Inspection Date: February 24, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · edf7a724-9ebf-4bca-85fb-31c6f2251350

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 771852
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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
May 25, 2011	OAI	Center for Devices and Radiological Health	Compliance: Devices