Is Light Age, Inc. Safe? FDA Warning Letter Review (2018)

Detailed Analysis

False Claims and Regulatory Violations

During an inspection of your firm located in Somerset, New Jersey on October 21, 2017 through November 17, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II, medical lasers, including but not limited to EpiCare and Q-Clear. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

3.    Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), a required by 21 CFR 820.100(a). Specifically, your Corrective and Preventive Action (CAPA) procedure, QSP-852-000, Rev 1, Effective Date: 07/15/2015 is not adequately implemented in that;

Potential Health Risks

Medical Devices and Radiological Health, Division 1 East1 Montvale AveStoneham, MA 02180

c.  Section 6.5, requires an investigation to determine the root cause or potential root cause; and section 6.6, requires risk assessment, for each NC. You were not able to provide documentation to demonstrate that an investigation nor risk assessment were conducted for the following open NCs, of which the devices have since been shipped:

2.  NC #00025, opened 02/03/2016, involved a EpiCare Duo-C, serial #502-16-663-DUO-C for shutter failure twice during the final QA testing and other units were reported with failures in the field. There was no investigation, root cause, assessment, risk level, or risk rationale documented.

Regulatory Context

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received your response, dated December 8, 2017, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1.    Failure to establish and maintain procedures to control product that does not conform to specified requirements, which shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).