FDA WARNING_LETTER - Caltag Medsystems Ltd - May 04, 2023

The FDA issued a Warning Letter to Whiteleaf Business Centre following an inspection from May 2-4, 2023, in Buckingham, UK. The firm manufactures TransFix/EDTA Vacuum Blood Collection Tubes (TVTs), classified as medical devices. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). Key violations include failures related to corrective and preventive action (CAPA) procedures (21 CFR 820.100), design review procedures (21 CFR 820.30(e)), design transfer procedures (21 CFR 820.30(h)), process validation for non-verifiable processes (21 CFR 820.75(a), a repeat violation), equipment calibration and maintenance (21 CFR 820.72(a)), and labeling control, including UDI accuracy (21 CFR 820.120(b)). The firm's May 26, 2023, response was deemed inadequate, lacking systemic corrective actions, evidence of implementation, or retrospective reviews. Whiteleaf Business Centre must provide a written response within 15 business days detailing corrective actions, including systemic changes, documentation, and a timetable. Failure to comply may result in regulatory actions like seizure, injunction, civil money penalties, and impact on federal contracts and device approvals.