Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistRandox Laboratories Limited, a United Kingdom-based manufacturer of diagnostic test systems (RX series, RX daytona, RX daytona+, and RX imola), failed to comply with FDA's Current Good Manufacturing Practice requirements under 21 CFR Part 820. During an August 2024 inspection, the FDA identified critical violations including failure to adequately validate device design and perform appropriate risk analysis, evidenced by five Class II recalls initiated since 2018 where assay reagents from previous tests carried over into subsequent assays, causing erroneous results. The devices were determined to be adulterated due to manufacturing, facility, and control deficiencies that did not meet quality system regulation standards.