FDA WARNING_LETTER - Rolence Ent. Inc. - July 11, 2024

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Record Details

On October 18, 2024, the FDA issued a Warning Letter to Chang Lin Chiu following an inspection of their Taoyuan, Taiwan facility from July 8-11, 2024. The inspection revealed that the firm's XR-01 Portable X-ray System, a Class II medical device, is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820. The firm's July 12, 2024 response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Design Control (21 CFR 820.30(a)):** Failure to conduct design validation, risk analysis, or design reviews for the XR-01 system, despite U.S. shipments since 2023. The firm's response lacked updated procedures, retrospective review, and training plans. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** No verification/validation of CAPA effectiveness (19 CAPAs reviewed from 2022-2024), and no documented evidence of implementation. The response lacked supporting documentation, retrospective review, and training plans. 3. **Complaint Handling

Company: Rolence Ent. Inc.
Inspection Date: July 11, 2024
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Shu-Chen Cheng
Robert A. Ochs (Office Director)

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ID · a6250086-89e0-4204-90bb-612f669fdd33

Violation Codes10

21 U.S.C. 321(h)21 U.S.C. 351(h)21 CFR 82021 CFR 820.30(a)21 CFR 820.100(a)21 CFR 820.198(a)21 CFR 820.8621 CFR 820.70(i)21 CFR 820.12021 CFR 820.184

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