Micro-X Ltd. – FDA Warning Letter, May 23, 2024

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(