Corentec Co., LTD – FDA Inspection, Apr 9, 2015

Record Details

This FDA Inspection record concerns Corentec Co., LTD, with an inspection on April 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Corentec Co., LTD
Inspection Date: April 9, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a600209e-914c-41c9-ab6b-096ed9e6a89e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 924849
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 806.20(b)(5)Records of communications
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.20(c)Management review - 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 820.184DHR content
21 CFR 820.75(c)Documentation - review in response to changes or deviations

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Other FDA inspections of Corentec Co., LTD

Date	Classification	Office	Project area
August 29, 2024	VAI	Center for Devices and Radiological Health	Compliance: Devices
October 31, 2019	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 19, 2017	Not classified	Office of Inspections and Investigations
January 16, 2014	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices