483
Randox Laboratories LimitedFDA 483 - Randox Laboratories Limited - August 08, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · bdabdd50-8385-47d2-bd61-250f6555384f