FDA 483 - Magellan Diagnostics, Inc. - August 26, 2025

Magellan Diagnostics, Inc. in North Billerica, MA, was inspected regarding its blood lead testing systems. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate corrective and preventive actions, design verification, process validation, incoming product acceptance, and risk analysis. Furthermore, the firm failed to timely report numerous medical device malfunctions and a field correction to the FDA, indicating a systemic breakdown in quality management and regulatory compliance that could impact patient safety.