# FDA 483 - MD DIAGNOSTICS LTD. - March 04, 2019

Source: https://www.keypedia.com/records/483/md-diagnostics-ltd/be9a0001-0d09-4c07-a8db-84530f73b33e

> FDA 483 for MD DIAGNOSTICS LTD. on March 04, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MD DIAGNOSTICS LTD.
- Inspection Date: 2019-03-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of MD DIAGNOSTICS LTD. in Maidstone, Kent, England, revealed two significant observations. The firm failed to implement written Medical Device Reporting (MDR) procedures and lacked verification in the Design History File for the CO Check Plus device regarding its performance over its expected life. These issues indicate deficiencies in quality system requirements related to post-market surveillance and design control.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/md-diagnostics-ltd/4fdf2cec-0a70-4198-ac21-acf7475f96ee

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