Xoran Technologies, LLC – FDA Warning Letter, Jul 11, 2024

On December 9, 2024, the FDA issued a Warning Letter to a firm in Ann Arbor, MI, following an inspection from June 25 to July 11, 2024. The firm manufactures CT systems and software, including MiniCAT 2020, MiniCAT IQ, xCAT IQ, xCAT XL, and XoranConnect. These devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain procedures for purchased products and services (21 CFR 820.50):** The firm did not implement supplier assessment procedures, specifically failing to ensure two PCB suppliers conducted process validations for soldering processes, leading to PCB failures and replacements in MiniCAT 2020 and MiniCAT IQ devices. The firm's responses were inadequate, lacking a comprehensive review of supplier files and risk assessment for existing inventory and field devices. 2. **Failure to adequately validate device design, including software (21 CFR 820.30(g)):** The XoranCAT software (v5.17.3) was not adequately validated, with validation documentation lacking component and integration testing despite numerous software-related complaints. The firm's responses were