Loading…
Meridian Bioscience, Inc. was cited for manufacturing adulterated in-vitro diagnostic (IVD) devices, specifically blood lead level analyzers and test kits (LeadCare II), that failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. During an FDA inspection of the company's Magellan Diagnostics facility in North Billerica, MA conducted from August 5-26, 2025, investigators identified violations including failure to establish and maintain procedures for corrective and preventive action (CAPA), along with deficiencies in analyzing processes, work operations, and quality audit reports. The company submitted multiple responses to the FDA 483 observations between September and December 2025, but the violations were not adequately resolved, prompting the formal warning letter issued on December 22, 2025.