NIDEK Co., Ltd. – FDA Inspection, Jul 31, 2014

Record Details

This FDA Inspection record concerns NIDEK Co., Ltd., with an inspection on July 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: NIDEK Co., Ltd.
Inspection Date: July 31, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b6b760a2-6afe-4e60-9094-42ffde903029

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 890755
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures

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Other FDA inspections of NIDEK Co., Ltd.

Date	Classification	Office	Project area
September 14, 2018	Not classified	Office of Inspections and Investigations
December 8, 2017	Not classified	Office of Inspections and Investigations
June 1, 2017	Not classified	Office of Inspections and Investigations	Project Evaluation: Devices
February 18, 2010	NAI	Center for Devices and Radiological Health	Compliance: Devices