483
Magellan Diagnostics, Inc.Magellan Diagnostics, Inc. – FDA 483, Jun 22, 2021
Record Details
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.
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ID · c57ffd9f-7b18-4179-8e24-a55f44ac4b67
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