Marina Medical Instruments Inc. – FDA Inspection, Dec 5, 2008

Record Details

This FDA Inspection record concerns Marina Medical Instruments Inc., with an inspection on December 5, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company: Marina Medical Instruments Inc.
Inspection Date: December 5, 2008
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 920343ff-7864-47ea-882b-2c7cb962bf98

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 550114
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.198(a)General
21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
21 CFR 820.20Management responsibility
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.70(a)Process control procedures
21 CFR 820.75(a)Documentation
21 CFR 820.22Quality Audit/Reaudit - conducted

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Other FDA inspections of Marina Medical Instruments Inc.

Date	Classification	Office	Project area
April 3, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 9, 2014	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 9, 2014	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 9, 2014	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 2, 2012	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices