Joylux, Inc. – FDA 483, Jun 15, 2026

Joylux, Inc., a medical device specification developer in Seattle, WA, received a Form FDA 483 with two observations. The firm was cited for failing to ensure medical devices had unique device identifiers (UDI) on their labels and for not adequately documenting procedures for timely complaint handling. These observations highlight deficiencies in the firm's quality system for medical devices.