FDA 483 - Magellan Diagnostics, Inc. - June 22, 2021

Magellan Diagnostics, Inc. in North Billerica, MA was inspected by the FDA from June 2-22, 2021, and received one observation. The inspection revealed inadequate validation of a process used in the production of LeadCare blood lead test kits. This deficiency led to the distribution of unvalidated test kits, some of which were subsequently recalled.