Micro-X Ltd.

Warning LetterOpen

Kingsley Hall Chief Executive Officer Micro-X Ltd. 6 MAB Eastern Promenade, Unit 14 Tonsley SA 5042 Australia khall@micro-x.comFEI 3012855798Issued Sep 10, 2024Center for Devices and Radiological Health

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Letter Details

Firm: Micro-X Ltd.
Location: Kingsley Hall Chief Executive Officer Micro-X Ltd. 6 MAB Eastern Promenade, Unit 14 Tonsley SA 5042 Australia khall@micro-x.com
FEI Number: 3012855798
Country: Australia
Issue Date: September 10, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Micro-X Ltd., an Australian medical device manufacturer, was cited for adulteration of its Micro-X Rover Mobile X-Ray Systems due to failure to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The primary violation involved inadequate design change control procedures, specifically the improper processing of design changes through Manufacturing Deviation protocols (SOP025-5.1) instead of the required Design Change Control procedures (SOP002 and WI002A), which failed to ensure proper validation, verification, and approval before implementation. The FDA inspection was conducted May 20-23, 2024, and the company's June 14, 2024 response to the Form FDA 483 observations was found to be insufficient in addressing the identified deficiencies.