FDA WARNING_LETTER - Magellan Diagnostics, Inc. - June 29, 2017

An FDA inspection of Magellan Diagnostics, Inc. from May 10 to June 29, 2017, identified significant violations for its LeadCare Blood Lead Testing Systems. The LeadCare II and LeadCare Ultra Systems were deemed adulterated for lacking approved Premarket Approval (PMA) applications and misbranded for failing to notify FDA of significant labeling and design changes (510(k) requirements), such as adding specific blood sample incubation times. The firm's LeadCare Systems were also adulterated under 21 CFR Part 820 (Quality System regulation) due to deficiencies in design validation, risk analysis, complaint handling, corrective and preventive actions (CAPA), design change control, and nonconforming product procedures. Additionally, the LeadCare Ultra and LeadCare II Systems were misbranded under 21 CFR Part 803 (Medical Device Reporting) for failing to submit timely MDRs for malfunctions and for inadequate MDR procedures. The firm also failed to submit required reports of corrections and removals under 21 CFR Part 806 within 10 working days for customer notices regarding incubation times and revised control values. Magellan Diagnostics' responses were deemed inadequate, lacking sufficient supporting documentation for corrective actions. The FDA requires prompt, comprehensive corrective actions within fifteen business days to avoid further regulatory action, including seizure, injunction, civil penalties, and impacts on federal contracts and device approvals.