# FDA WARNING_LETTER - Micro-X Ltd. - May 23, 2024

Source: https://www.keypedia.com/records/warning_letter/micro-x-ltd/fb507b84-af84-4d78-bc5e-91ea41dfb7dc

> FDA WARNING_LETTER for Micro-X Ltd. on May 23, 2024. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Micro-X Ltd.
- Inspection Date: 2024-05-23
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On September 10, 2024, the FDA issued a Warning Letter to Micro-X Rover Mobile X-Ray Systems, Tonsley, South Australia, following an inspection from May 20-23, 2024. The inspection revealed the firm's Micro-X Rover Mobile X-Ray Systems are adulterated under 21 U.S.C. § 351(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2).

Key violations include:
1.  **Design Change Control (21 CFR 820.30(i)):** Failure to adequately establish and maintain procedures for design change validation/verification. Multiple design changes were processed as manufacturing deviations without proper verification/validation. The firm's response was inadequate, lacking documentation of updated procedures, training, or a retrospective review.
2.  **Design Validation (21 CFR 820.30(g)):** Failure to validate the use and integration of software and panels in the MXU-RV71 system, or document justification for not validating. The firm's response was inadequate, lacking documentation of validation or a retrospective review.
3.  **CAPA Procedures (21 CFR 820.100(

## Related Officers

- [Office Director](https://www.keypedia.com/people/robert-a-ochs/27079757-05e8-4cf3-ac53-9b83b4b60624)
- [Greg Swanson](https://www.keypedia.com/people/greg-swanson/4c2e2a93-8ba4-42bc-9d97-47cdb2290148)

Company: https://www.keypedia.com/companies/micro-x-ltd/6dae7c0a-d5db-41e6-84ab-def71991216c

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7