1Other quality system
Procedures for design change have not been established.
Inspection Record
Micro-X Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Procedures for corrective and preventive action have not been adequately established.
3Other quality system
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
4Complaint and recall handling
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
5Other quality system
A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
About this record
Extracted automatically from the document US FDA published on 2026-07-28. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
