483
MD DIAGNOSTICS LTD.MD DIAGNOSTICS LTD. – FDA 483, Mar 4, 2019
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.
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ID · be9a0001-0d09-4c07-a8db-84530f73b33e
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