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# 12 QS Issues in Light Age Inspection
- URL: https://www.fdaweb.com/12-qs-issues-in-light-age-inspection/
- Published: 2018-01-30T12:00:00.000Z
- Updated: 2026-09-14T23:18:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140627

A 10/21-11/17/17 FDA inspection at Light Age, Inc., Somerset, NJ, found 12 Quality System Regulation violations in the firm’s manufacturing of Class 2 medical lasers, including EpiCare and Q-Clear. A 1/24 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm593900.htm?ref=fdaweb.com) says specific violations listed on an FDA-483 were: 

- failing to establish and maintain procedures to control product that does not conform to specified requirements, addressing the identification, documentation, evaluation, segregation, and disposition of nonconforming product;
- failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish and maintain procedures for implementing corrective and preventive actions;
- failing to establish and maintain procedures that include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, service records, complaints, return product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems;
- failing to review, evaluate, and investigate complaints involving possible failure of a device to meet its specifications;
- failing to have management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, to ensure the quality system satisfies regulatory requirements;
- failing to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with established quality system requirements and to determine quality system effectiveness;
- failing to maintain a device master record;
- failing to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained;
- failing to maintain device history records to demonstrate that devices are manufactured in accordance with regulations;
- failing to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation; and
- failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.

The firm’s responses to the inspection observations were not adequate, the letter says. FDA told Light Age to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with a timetable for completion. “Your firm’s response should be comprehensive and address all violations included in this Warning Letter,” FDA says.