FDA 483 - Xtreem Pulse LLC - June 19, 2019

An FDA inspection of Xtreem Pulse LLC, a medical device manufacturer in New York, revealed significant deficiencies in its quality system. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR), Corrective and Preventive Actions (CAPA), and the handling of consumer complaints. These observations indicate a fundamental lack of critical operational controls.