FDA 483 - Empowered Products, Inc. - October 29, 2025

An FDA inspection of Empowered Products, Inc. in Las Vegas, NV, a manufacturer of Class II medical devices, revealed significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for complaint handling, corrective and preventive actions, personnel training, and vendor evaluations. These issues indicate systemic problems in maintaining quality records and ensuring product conformity.