Meridian Bioscience, Inc

Warning LetterOpen

Tony Serafini-Lamanna President of Diagnostics Meridian Bioscience, Inc 3471 Riverhills Dr. Cincinnati , OH 45244 United States Tony.Serafini-Lamanna@meridianbioscience.comFEI 1524213Issued Dec 22, 2025Center for Devices and Radiological Health

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Violations8

Issue DateDec 22, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Meridian Bioscience, Inc
Location: Tony Serafini-Lamanna President of Diagnostics Meridian Bioscience, Inc 3471 Riverhills Dr. Cincinnati , OH 45244 United States Tony.Serafini-Lamanna@meridianbioscience.com
FEI Number: 1524213
Country: United States
Issue Date: December 22, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Meridian Bioscience, Inc FDA Warning Letter, December 22, 2025