Nidek, Inc. – FDA Inspection, Apr 14, 2014

Record Details

This FDA Inspection record concerns Nidek, Inc., with an inspection on April 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Nidek, Inc.
Inspection Date: April 14, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · df775622-b46b-4152-b089-a23899e002d8

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 871244
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 820.184DHR - not or inadequately maintained
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(b)Documentation
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.25(b)Training records
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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Other FDA inspections of Nidek, Inc.

Date	Classification	Office	Project area
January 24, 2019	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 31, 2017	NAI	Center for Devices and Radiological Health	Compliance: Devices
August 10, 2016	NAI	Center for Devices and Radiological Health	Compliance: Devices
June 10, 2015	NAI	Center for Devices and Radiological Health	Compliance: Devices
July 30, 2013	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices