FDA WARNING_LETTER - Meridian Bioscience Inc - August 26, 2025

Meridian Bioscience, Inc., specifically its Magellan Diagnostics, Inc. facility in North Billerica, MA, received an FDA Warning Letter dated December 22, 2025. This letter followed an inspection from August 5 to August 26, 2025, which focused on the manufacture of in-vitro diagnostic kits, including the LeadCare II Blood Lead Analyzer and Test Kit. The FDA determined that the company"s devices were adulterated due to non-conformity with the current good manufacturing practice requirements of the Quality System Regulation (21 CFR Part 820).

Key violations included a failure to establish and maintain effective corrective and preventive action (CAPA) procedures, demonstrated by not initiating CAPAs for an increase in patient false positive complaints and numerous out-of-range control complaints. The firm also failed to establish appropriate design input requirements for the Level 1 and Level 2 Controls used in its LeadCare II system. Additionally, the company did not adequately validate device design, specifically failing to validate cleaning instructions for its LeadCare analyzers and to update risk management files. The FDA found the company"s responses inadequate, requiring a demonstration of effective corrective actions, including retrospective reviews, revised design documents, and comprehensive plans for assessing their design control program.