FDA 483 - Xtreem Pulse LLC - October 13, 2023

An FDA inspection of Xtreem Pulse LLC in New York, NY, a manufacturer and specification developer of Class II transcutaneous electrical stimulator devices, revealed significant deficiencies in their quality system. Observations included the failure to establish a design history file, inadequate procedures for accepting incoming products, and insufficient procedures for managing design changes. These issues suggest a lack of proper controls over product design and manufacturing processes.