MD DIAGNOSTICS LTD.March 4, 2019

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

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Record Details

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.

Company: MD DIAGNOSTICS LTD.
Inspection Date: March 4, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Stephen D. Eich (investigator)

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