# FDA 483 - Mi3 Limited - August 18, 2022

Source: https://www.keypedia.com/records/483/mi3-limited/c8ed1f41-03df-4863-be4e-7300b43142f0

> FDA 483 for Mi3 Limited on August 18, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mi3 Limited
- Inspection Date: 2022-08-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Mi3 Limited, a medical device manufacturer in Blackburn, Lancashire, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate validation of manufacturing equipment and processes, insufficient risk analysis updates for new failure modes, and failures to document the disposition of nonconforming products. Additionally, the firm lacked clear definitions for controlling suppliers and contractors.

## Related Documents

- [483 - 2020-02-06](https://www.keypedia.com/records/483/mi3-limited/433d4dfb-8a32-4988-8eb3-3cef3c927caa)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/mi3-limited/55d2cf66-736b-4d6a-af09-d60ba3bd11e8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd