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Rolence Ent. Inc., a Taiwan-based manufacturer of the XR-01 Portable X-ray System, was cited for failing to establish and maintain adequate design control procedures required under the Quality System Regulation (21 CFR 820.30), including a complete absence of design validation, risk analysis, and design reviews despite shipping the Class II device to the U.S. since 2023. The inspection conducted July 8-11, 2024 determined the devices were adulterated due to manufacturing methods and controls not conforming to current good manufacturing practice (CGMP) requirements. The company's July 12, 2024 response, which claimed incomplete information was provided during inspection and referenced existing procedures, was deemed inadequate by the FDA.