FDA WARNING_LETTER - Light Age, Inc. - November 17, 2017

On October 21, 2017, an FDA inspection of Light Age, Inc. in Somerset, New Jersey, revealed that the firm's Class II medical lasers, including EpiCare and Q-Clear, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Nonconforming Product Control (21 CFR 820.90(a)):** Failure to establish and maintain procedures for nonconforming product. The firm did not implement its Non-conformance procedure (QSP-830-000), with undocumented non-conformances, unreviewed records, and lack of root cause investigations or risk assessments for open non-conformances, some of which involved shipped devices. The firm's response was inadequate, lacking retrospective reviews and updated procedures/training. 2. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. The Complaint Investigation Procedure (QSP-919-000) was not implemented, with missing root cause investigations or rationales, and inability to locate several complaint records. The response was inadequate, lacking retrospective review and revised