# FDA 483 - MatOrtho Ltd - March 05, 2020

Source: https://www.keypedia.com/records/483/matortho-ltd/a0334aa3-c09d-4a24-9558-44811dde380c

> FDA 483 for MatOrtho Ltd on March 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MatOrtho Ltd
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of MatOrtho Ltd, a medical device manufacturer in Leatherhead, United Kingdom, revealed seven significant deficiencies in their quality system. The firm failed to adequately manage complaints, validate design changes, verify labeling accuracy, and establish proper procedures for finished device acceptance, corrective actions, and nonconforming product control. These observations indicate a need for improved adherence to regulatory requirements to ensure device quality and safety.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/matortho-ltd/6151c514-3865-4737-9b65-a394e12197e6

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