FDA EIR - Xtreem Pulse LLC - June 19, 2019

An FDA inspection of Xtreem Pulse LLC, a medical device specification setter and importer located in New York, was conducted from June 11 to June 19, 2019. The inspection focused on Medical Device and Radiological Health Operations, encompassing Design Controls, Corrective and Preventive Actions, and Medical Device Reporting (MDR) regulations. Xtreem Pulse LLC specializes in External Counter-Pulsation Devices, though no devices had been marketed or sold in the USA, and no manufacturing was conducted on-site. The inspection culminated in the issuance of a Form FDA-483, detailing three significant observations. The company lacked established written procedures for Medical Device Reporting, which are essential for handling incidents involving deaths or serious injuries (21 CFR 803.17). Furthermore, Xtreem Pulse LLC had not developed procedures for corrective and preventive actions to investigate medical devices (21 CFR 820.100(a)). Lastly, the firm failed to establish written procedures for receiving, reviewing, and evaluating customer complaints (21 CFR 820.198(a)). Management acknowledged these findings and committed to implementing corrections. Xtreem Pulse LLC was instructed to submit a formal written response to the FDA within 15 business days, detailing their plan to address these critical compliance issues.