Midmark Corporation – FDA Inspection, Sep 12, 2011

Record Details

This FDA Inspection record concerns Midmark Corporation, with an inspection on September 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Midmark Corporation
Inspection Date: September 12, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · c9852ca2-4c0c-46d5-b403-b8f7e2a3e55b

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 742849
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
21 CFR 820.180(b)Retention period
21 CFR 803.17Lack of Written MDR Procedures

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Other FDA inspections of Midmark Corporation

Date	Classification	Office	Project area
August 15, 2019	Not classified	Cincinnati District Office
April 2, 2018	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
December 9, 2016	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 9, 2014	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 28, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices