# FDA 483 - Micro-X Ltd. - January 15, 2026

Source: https://www.keypedia.com/records/483/micro-x-ltd/ec869200-bdc1-4220-bc58-060002f91223

> FDA 483 for Micro-X Ltd. on January 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro-X Ltd.
- Inspection Date: 2026-01-15
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Micro-X Ltd. in Tonsley, South Australia, a medical device manufacturer, was cited for significant deficiencies in its quality system. The firm failed to adequately establish and implement procedures for design changes, leading to unverified field corrections. Additionally, the inspection revealed inadequate procedures for receiving, reviewing, and evaluating customer complaints, resulting in numerous potential complaints not being properly documented or assessed for Medical Device Reporting.

## Related Documents

- [483 - 2024-05-23](https://www.keypedia.com/records/483/micro-x-ltd/5ed9d6e1-23c6-4e7b-973f-efcb2c96fad2)
- [WARNING_LETTER - 2024-05-23](https://www.keypedia.com/records/warning_letter/micro-x-ltd/fb507b84-af84-4d78-bc5e-91ea41dfb7dc)
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## Related Officers

- [Karen M. Cruz Arenas](https://www.keypedia.com/people/karen-m-cruz-arenas/6c698301-84ca-4ba7-a79c-309721db2f1b)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8