CURALLUX LLC – FDA Inspection, Nov 7, 2014

Record Details

This FDA Inspection record concerns CURALLUX LLC, with an inspection on November 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: CURALLUX LLC
Inspection Date: November 7, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 9055b9f3-cce2-4412-b150-a9458f2bbe97

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 900767
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.198(a)Complaints
21 CFR 820.100(b)Documentation
21 CFR 1010.2(a)Lack of certification of conformance
21 CFR 1040.10(h)(1)(iii)Legible reproductions
21 CFR 820.160(a)Lack of or inadequate procedures for distribution
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures

Showing 10 of 17 citations.

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Other FDA inspections of CURALLUX LLC

Date	Classification	Office	Project area
June 7, 2019	Not classified	Florida District Office
April 17, 2019	NAI	Center for Devices and Radiological Health	Compliance: Devices
August 9, 2017	Not classified	Florida District Office
May 10, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 16, 2013	OAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act