FDA 483 - Light Age, Inc. - March 11, 2020

An FDA inspection of Eight Age, Inc. in Somerset, NJ, revealed significant deficiencies across its quality system, particularly in corrective and preventive actions, complaint handling, and management oversight. The firm failed to adequately establish and maintain procedures for critical quality processes, including internal audits, equipment calibration, and document control. These findings indicate a systemic lack of adherence to quality system requirements for this medical device manufacturer.