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WARNING LETTER

Micro-X Ltd. MARCS-CMS 692084 —

Delivery Method:
Via Email
Product:
Medical Devices
Recipient:
Recipient Name
Kingsley Hall
Recipient Title
Chief Executive Officer
Micro-X Ltd.

6 MAB Eastern Promenade, Unit 14
Tonsley SA 5042
Australia

khall@micro-x.com
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER

September 10, 2024

Dear Mr. Hall:

During an inspection of your firm located in Tonsley, South Australia on May 20, 2024, through May 23, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Micro-X Rover Mobile X-Ray Systems. 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 Jolanta Ganzarczyk, dated June 14, 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 adequately establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, your Design Change Control procedure, SOP002, and Design Change Management - Medical Devices, WI002A, address the processing of design changes, the former document requiring a determination of all actions for a design change, including validation and verification. However, multiple design changes were instead processed using Manufacturing Deviation, SOP025-5.1, intended for temporary deviations from manufacturing procedures. For example, (b)(4). Your firm’s Manufacturing Deviation Permit, FSOP025A-6.0, stated that these are changes to the product(s) fit, form, or function; the documentation does not include verification/validation results to ensure no adverse effect on the device.

We reviewed your firm’s response and conclude that it is not adequate. You have planned to update your firm’s procedure for design changes and to train personnel in the verification and validation activities, however, no documentation to this effect has to be presented. As part of the correction, your response does not include/reference a retrospective review of previous design changes to ensure design changes have been properly verified and validated.

2. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically, your firm failed to validate the use and integration of the (b)(4) software and (b)(4) panels used in the Micro-X Rover Mobile X-ray System MXU-RV71. Your firm failed to document justification for the decision not to validate.

We reviewed your firm’s response and conclude that it is not adequate. In your response, you plan to update the validation plan for MXU-RV71; however, documentation of validation has yet to be provided. Additionally, your response does not include a retrospective review of other design documentation to ensure all designs have been adequately validated.

3. Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, Quality Event and CAPA procedure, SOP006, fails to require that appropriate statistical methodology be employed where necessary to detect recurring quality problems, in order to identify existing and potential causes of nonconforming product.

We reviewed your firm’s response and conclude that it is not adequate. You stated that nonconforming product/parts are to be investigated and analyzed/trended as per SOP005 Control of Nonconforming Product procedure. Specifically, you have planned to review the SOP006 Quality Event & CAPA and include additional sources of quality data. Your firm plans to update the CAPA form to include review of manufacturing records, device history files, and field service tickets when investigating a quality event. No documentation of the planned corrective actions has yet to be provided. However, your firm’s response does not include a retrospective review of quality data using statistical methodology in order to determine whether there exist potential causes of nonconforming product.

4. Failure to adequately ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a)(3). Specifically, the complaints of reported malfunctions of the Micro-X Rover Mobile X-ray Specifically, the Customer Complaint Form, FSOP007A – 6.0, does not appear to have a field specifying whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803. Multiple complaint documents (e.g., CC022-23, CC017-23, CC004-23, CC010-23) did not explicitly include a determination of MDR reportability.

We reviewed your firm’s response and conclude that it is not adequate. Your firm has planned to update the Customer Complaint Management procedure, and to review previous customer complaints and include a rationale and justification for non-reporting. However, no documentation of the corrective actions has yet to be provided. Additionally, your firm’s corrective action plan does not include employee training.

Our inspection also revealed that your firm’s Micro-X Rover Mobile X-Ray Systems 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 806 – Medical Device; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

5. Failure to report a medical device correction or removal to FDA, initiated to remedy a violation which may present a risk to health, as required by 21 CFR 806.10(a). Specifically, your firm failed to report the following 2 field corrections conducted to reduce a risk to health posed by Micro-X Rover Mobile X-ray Systems:

a. Service Bulletin, SB006-23, for the Micro-X Rover RV19, Micro-X Rover RV35, and Micro-X Rover RV80, was issued to reduce the risk of on-screen keyboard inaccessibility and to ensure the on-screen keyboard will be accessible in other user profiles. Per CAPA024-22, (b)(4) with Varex, your firm’s software contract manufacturer, to rectify the issue. The CAPA identified the associated risks as an inability to enter patient data, annotate images with text, and configure the system with text.

b. Service Bulletin, SB007-23-1.0, for the Micro-X Rover was issued due to generator failure in extreme humidity environments, which can adversely affect the performance and integrity of the product (e.g., the system may cease to function). Per CAPA024-22, your firm instituted multiple component changes (e.g., (b)(4)) to reduce likelihood of occurrence of the hazard.

We reviewed your firm’s response and conclude that it is not adequate. You have promised to implement corrective actions such as “[d]evelop a procedure/work instruction for issuing Service Bulletins” and “[r]egulatory reporting process for design changes to be developed”. You have also promised to retroactively report the 806 actions to FDA and listed a completion date of September 30, 2024. However, no documentation of the corrections has been provided.

In addition to being a medical device, the mobile X-ray systems are electronic products subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control (EPRC), the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010 and 1020.30. Your firm failed to comply with the following regulation:

6. Any manufacturer who discovers that any electronic product produced, assembled, or imported by him, which product has left its place of manufacture, has a defect or fails to comply with an applicable Federal standard shall immediately notify the Secretary in accordance with 21 CFR 1003.20, as required by 21 CFR 1003.10(a). Specifically, your firm failed to notify FDA of the following product defects and/or failure(s) to comply with an EPRC performance standard, which had resulted in corrective actions for the Micro-X Rover Mobile X-ray Systems:

a. Service Bulletin, SB003-23, covered a firmware update to reduce the risk of repeat exposure due to occurrence of a critical error during short pulse duration exposures with the Micro-X Rover RV35. This is considered a defect per 21 CFR 1003.2(b)(1) in that the product utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, it fails to conform to its design specifications relating to the emission of electronic product radiation.

b. Service Bulletin, SB002-22, covered the installation of an exposure switch holder on the Rover Mobile X-ray to reduce the likelihood of the exposure button being pressed inadvertently while stored. The is considered a defect per 21 CFR 1003.2(b)(1). Any such inadvertent exposure would also be reportable as an Accidental Radiation Occurrence under 21 CFR 1002.20.

c. Modification 017 covered the replacement of (b)(4) (or earlier) of the Micro-X Rover RV35 and Micro-X Rover RV71 due to a lower post exposure (b)(4) than the operator’s setting. (b)(4). Per 21 CFR 1020.31(a)(4), deviation of technique factors from indicated values shall not exceed the limits given in the information provided in accordance with 21 CFR 1020.30(h)(3).

We reviewed your firm’s response and conclude that it is not adequate. You have promised to implement corrective actions such as “Develop a procedure/work instruction for issuing Service Bulletins” and “Regulatory reporting process for design changes to be developed”. You have also promised to retroactively report the 806 actions to FDA and listed a completion date of September 30, 2024. However, no documentation of the corrections has been provided.

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 #692084 when replying. If you have any questions about the contents of this letter, please contact: Lu Jiang at lu.jiang@fda.hhs.gov or +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.

Sincerely,
/S/

Robert Ochs, Ph.D.
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc:
Greg Swanson
U.S. Agent
Emergo Global Consulting LLC
2500 Bee Cave Rd., Bldg. 1, Ste. 300
Austin, Texas 78746
USAgent@ul.com

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