FDA 483 - Randox Laboratories Limited - August 08, 2024

An FDA inspection of Randox Laboratories Limited in Antrim, United Kingdom, revealed significant deficiencies in risk analysis and corrective and preventive action procedures. The firm has failed to adequately address "carryover" issues in its Rx series Analyser instruments, which have led to five Class II Recalls due to erroneous assay results. These issues indicate a lack of systematic control to prevent recurrence of product quality problems.