FDA 483 - Randox Laboratories Limited - August 08, 2024

On August 8, 2024, the FDA issued a Form 483 to Randox Laboratories Limited, a manufacturer located at 30 Randalstown Road, Antrim, County Antrim, BT41 1FL, United Kingdom, following an inspection from August 5-8, 2024. The inspection revealed two observations.

Observation 1 states that risk analysis is inadequate. Specifically, since December 2018, Randox Laboratories Limited has initiated five Class II Recalls (Event IDs 81184, 88636, 91097, 92850, 93375) related to "carryover" of reagents from previously used assays to the next assay test on their private label distributed RX series Analyser instruments (RX Daytona and RX Imola), causing erroneous results. Despite their procedure RQN-107, Rev 0, June 23, 2023, section 5.11, requiring updates to Risk Management Reports (RMRs) for new hazards, the firm has not updated all relevant RMRs, such as the Risk Analysis Copper (CCu) cat/ Prod No. CV2230, Rev. 0, dated July 22, 2020, to address these identified hazards and implement mitigations.

Observation 2 indicates that procedures for