Rolence Ent. Inc.

Warning LetterOpen

Chang Lin Chiu General Manager Rolence Ent. Inc. No. 18-3, Lane 231 Pu Chung Road Taoyuan District , Taoyuan City 32083 Taiwan (b)(4)@rolence.com.twFEI 3002772487Issued Oct 18, 2024Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002772487.

Violations12

Issue DateOct 18, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Rolence Ent. Inc.
Location: Chang Lin Chiu General Manager Rolence Ent. Inc. No. 18-3, Lane 231 Pu Chung Road Taoyuan District , Taoyuan City 32083 Taiwan (b)(4)@rolence.com.tw
FEI Number: 3002772487
Country: Taiwan
Issue Date: October 18, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Rolence Ent. Inc. FDA Warning Letter, October 18, 2024