FDA 483 - LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD) - October 26, 2023

Late Night Concepts Inc., operating as Brux Night Guard, a medical device manufacturer in West Hills, CA, was inspected by the FDA. The inspection revealed one significant observation concerning the firm's inadequate procedures for design transfer. Specifically, the firm failed to maintain records demonstrating that the design of the Brux Night Guard medical device was correctly translated into production specifications by its contract manufacturers.