# FDA 483 - Mi3 Limited - February 06, 2020

Source: https://www.keypedia.com/records/483/mi3-limited/433d4dfb-8a32-4988-8eb3-3cef3c927caa

> FDA 483 for Mi3 Limited on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mi3 Limited
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MI3 Limited, a medical device contract manufacturer in Blackburn, United Kingdom, was inspected by the FDA from February 3-6, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning process validation, corrective and preventive actions, risk analysis, and sampling plans. These issues indicate a lack of adequate controls to ensure the quality and safety of their manufactured medical devices, specifically the High Flow Insufflation Set.

## Related Documents

- [483 - 2022-08-18](https://www.keypedia.com/records/483/mi3-limited/c8ed1f41-03df-4863-be4e-7300b43142f0)

## Related Officers

- [Shaquenta Perkins](https://www.keypedia.com/people/shaquenta-perkins/00369bbd-5784-42c2-847e-202c8b1b87a2)

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