FDA 483 - Xtreem Pulse LLC - June 29, 2022

An FDA inspection of Xtreem Pulse LLC, a specification developer in New York, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design changes, purchasing controls, and overall design control for their PureLift Face and PureLift Pro facial stimulation devices. These issues indicate a lack of documented processes for critical aspects of medical device development and manufacturing.