FDA 483 - Xtreem Pulse LLC - October 13, 2023

During an inspection conducted from October 6 to October 13, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Xtreem Pulse LLC, a manufacturer and specification developer located in New York, NY. The inspection revealed several significant observations related to the company's quality system for its Class II medical devices, including the PureLift Face, PureLift Pro, PureLift Pro Plus, and PureLift Activator Serum.

A primary observation noted the absence of an established design history file for the PureLift Activator Serum, a crucial regulatory requirement for documenting the design and development of medical devices. Furthermore, the company lacked established procedures for the acceptance of incoming products, specifically for the PureLift devices received from their contract manufacturer. The existing "spot check" sampling method lacked statistical justification, and records of such inspections were not provided.

Finally, Xtreem Pulse LLC was cited for inadequate procedures concerning design changes. The firm implemented a design change for its PureLift devices between December 2022 and June 2023 without proper documentation, validation/verification, review, or approval processes, and without conducting necessary design verification testing. These observations indicate a need for Xtreem Pulse LLC to implement robust quality system controls to ensure compliance with medical device regulations. The firm is responsible for self-auditing and correcting all identified violations.