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

Source: https://www.keypedia.com/records/warning_letter/rolence-ent-inc/a6250086-89e0-4204-90bb-612f669fdd33

> FDA WARNING_LETTER for Rolence Ent. Inc. on July 11, 2024. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rolence Ent. Inc.
- Inspection Date: 2024-07-11
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Documents

- [483 - 2024-07-11](https://www.keypedia.com/records/483/rolence-ent-inc/a7bf6f55-338b-49d9-91fd-68b8deb87aa5)

## Related Officers

- [Office Director](https://www.keypedia.com/people/robert-a-ochs/27079757-05e8-4cf3-ac53-9b83b4b60624)
- [Shu-Chen Cheng](https://www.keypedia.com/people/shu-chen-cheng/317c6727-eb47-48c0-86a5-53ef219c565e)

Company: https://www.keypedia.com/companies/rolence-ent-inc/7cfe1f77-0669-42b7-8e45-5b187d445fe3

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7