Rolence Ent. Inc.

During an inspection of your firm located in Taoyuan, Taiwan on July 8, 2024, through July 11, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures XR-01 Portable X-ray System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from your firm dated July 12, 2024 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

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.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your firm’s response stated that the information provided during the inspection was incomplete, and you have procedures in place. Your firm’s response references plans to conduct design validation and design review. You also proposed additions to your “New Product Design and Development Process Procedures”, however the updated procedures were not included in the response for our evaluation. Also, your response did not include a retrospective review of all designs to ensure the device conforms to defined user needs and intended uses. Your response does not include a plan to train respective employees to ensure compliance with updated procedures.

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.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your firm’s response stated that your procedure does not record CAPAs clearly, and design changes based on CAPA implements an engineering change process, that include verification or validation to evaluate whether this action may cause any adverse events. You stated that the CAPA needs to be linked to the evidence documentation. However, documentation was not provided in the response for our evaluation. Also, your firm’s response did not include a retrospective review of implemented corrective and preventive actions to ensure that such action is effective and does not adversely affect the finished device. Additionally, your response does not include a plan to train respective employees to ensure compliance with updated procedures.

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.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your firm’s response stated you will clarify the evaluation process and repairing feedback shall create customer complaint or CAPA to follow up, however, no supporting documentation was provided for our evaluation. Your firm’s response did not include a retrospective review of the past two years to ensure all complaints/repairs were evaluated per the updated procedure. Also, your response does not include a plan to train respective employees to ensure compliance with updated procedures.

4. Failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86. Specifically, a unit of the XR-01 Portable X-ray System was not identified and/or accompanied with proper documentation throughout the manufacturing/assembly and testing processes. Your firm has no way to determine whether the unit was tested, rejected, reworked, and/or repaired. The unit is assigned a serial number (at labeling/packaging) after it passes the final tests.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your firm’s response states that they already have a process to conduct, control, and monitor production processes, and this was not provided during the inspection. However, your firm did not provide any supporting documentation for our evaluation. Also, your firm’s response did not include a retrospective review of production processes to ensure all devices conformed the specifications. Your firm’s response does not include a plan to train respective employees to ensure compliance with procedures.

5. 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.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your response stated that you already have a process to conduct, control, and monitor production processes, and this was not provided during inspection. You also stated that you will update your software quality control procedure. However, you did not provide any supporting documentation for our evaluation. Also, your response did not include a retrospective review of production processes to ensure all devices conformed the specifications. Your response does not include a plan to train respective employees to ensure compliance with procedures.

6. 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.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your response stated you will develop a labeling control process; however, your firm did not provide any supporting documentation for our evaluation. Also, your firm’s response did not include a retrospective review of labeling activities. Your response does not include a plan to train respective employees to ensure compliance with updated procedures.

7. Failure to establish and maintain adequate procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184. Specifically, your firm’s manufacturing procedures/working instructions for the Portable X-ray System are incomplete in that the procedures/working instructions do not require the technician(s) to document any of the assembly and packaging steps in the production record (showing that they were performed). Additionally, your firm’s DHRs from 2023 to 2024 pertaining to the Portable X-ray System do not include or refer to the location of the label and labeling used (primary label/UDI Label) for each production unit/lot/batch.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your firm’s response stated you have a document with the adequate procedures, INS-1500-1604 XR-01 X-ray device adjustment instruction, that was not provided during the inspection. However, no supporting documentation was provided for our evaluation. Also, your response did not include a retrospective review to ensure each unit was manufactured in accordance with the DMR. Your response does not include a plan to train respective employees to ensure compliance with procedures.

Our inspection also revealed that your firm’s XR-01 Portable X-ray System devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

8. 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: • It does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. • It does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. • It does not establish internal systems that provide for timely transmission of complete medical device reports. • It does not describe how your firm will address documentation and record-keeping requirements.

For example, during the inspection, your firm acknowledged the document titled “Incident Reporting Process”, No. A-14-02, Revision 2.3, dated 2021/5/27 as your written MDR procedures. However, upon review, it was concluded that the document does not contain information to indicate that it was developed as an MDR procedure in accordance with the requirements in 21 CFR 803.17. Specifically, the following deficiencies were noted:

a. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). i. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms ‘become aware’, ‘caused or contributed’, ‘malfunction’, ‘MDR reportable event’, and ‘serious injury’, and the definition for the term ‘reasonably suggests’, found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a). ii. The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate, or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803. iii. The procedure does not include instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.

b. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example, i. There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event. ii. The procedure, as written, does not specify who makes the decision for reporting events to FDA.

c. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include: i. Instructions for how to obtain and complete the FDA 3500A form. ii. The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, 5-day report and the requirements for such reports. iii. How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow-up within your firm.

d. The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b), including: i. Documentation of adverse event related information maintained as MDR event files. ii. Information that was evaluated to determine if an event was reportable. iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i). iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

Additionally, your firm is recommended to establish an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports. FDA verified that, as of September 20, 2024, your firm does not have such an account. Information about the ESG can be found at: How to Enroll in eMDR Program | FDA.

We reviewed your firm’s response dated July 12, 2024, and conclude that it is not adequate. Your response stated that you will develop the annex to the procedure No. A‐14‐02 to incorporate the 803.17 requirements. However, the updated procedure has not been provided for our evaluation. Also, your response did not include a retrospective review of events to determine whether they are subject to MDR requirement. Your response does not include a plan to train respective employees to ensure compliance with updated procedures.

Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov. Refer to CMS case #695010 when replying. If you have any questions about the contents of this letter, please contact: Lu Jiang, PhD, at +1-240-402-5779.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.