Rolence Ent. Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm did not conduct any design validation, risk analysis, or design reviews for the Class II XR-01 Portable X-ray System, despite having shipped the product to the U.S. since 2023.

Passage 2

Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, review of the CAPAs (19 CAPAs, from 2022 to 2024) revealed your firm did not conduct any verification/validation to ensure that such action is effective and does not adversely affect the finished device prior to implementation, and there is no documented evidence showing that your firm has implemented the proposed corrective actions.

Passage 3

Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, not all complaints are entered into your firm’s complaint handling system; instead many of these complaints (reviewed from 2022 to 2024) were logged and treated as repairs.

Passage 4

Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm has not validated the **(b)(4)** software (software application for X-ray quality control) used to perform the final tests of Portable X-ray Systems (i.e., tube voltage, exposure time, exposure, exposure rate, etc.) for its intended use according to an established protocol.

Passage 5

Failure to establish and maintain acceptance procedures to control labeling activities, as required by 21 CFR 820.120. Specifically, your firm has yet to establish procedures to control labeling activities for the Portable X-ray System to include: label integrity; labeling inspection; labeling storage; and labeling operations.

Passage 6

Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Specifically, your firm’s Incident Reporting Process Procedure, Document #A-14-02, is inadequate in that: