Marina Medical Instruments Inc. – FDA Inspection, Sep 1, 2011

Record Details

This FDA Inspection record concerns Marina Medical Instruments Inc., with an inspection on September 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Marina Medical Instruments Inc.
Inspection Date: September 1, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 05bceb87-213f-4c56-9038-0787da9daa41

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 742816
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audits - defined intervals
21 CFR 820.40(b)Document change records, maintained.
21 CFR 820.20(b)Lack of or inadequate organizational structure
21 CFR 820.50(b)Supplier notification of changes
21 CFR 803.17Lack of Written MDR Procedures

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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