Light Age, Inc. – FDA Inspection, Jul 1, 2022

Record Details

This FDA Inspection record concerns Light Age, Inc., with an inspection on July 1, 2022, issued by the Center for Devices and Radiological Health, covering devices.

Company: Light Age, Inc.
Inspection Date: July 1, 2022
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · 48d6a76d-703e-4b13-b6da-2b842a4bdfc5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1175964
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.198(a)Complaints
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.40(a)Document review, approval by designated individual
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures

Showing 10 of 17 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Light Age, Inc.

Date	Classification	Office	Project area
September 29, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 11, 2020	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 17, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices
December 20, 2012	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices