WARNING LETTER
Micro-X Ltd. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 692084
Micro-X Ltd..
6 MAB Eastern Promenade, Unit 14Tonsley SA 5042Australia
Dates: May 20, 2024, through May 23, 2024
Inspection Issue(s):
The report states, “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.”
These violations include, but are not limited to, the following:
- “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.”
- “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.”
- “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.”
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.
For more information, see the link below:
Micro-X Ltd. – 692084 – 09/10/2024 | FDA
