Targeted Genomics, LLC – FDA 483, Mar 26, 2026

An FDA inspection of Targeted Genomics, LLC in Irvine, CA, a manufacturer of genetic testing kits, revealed two significant observations. The firm failed to apply a risk-based approach to its quality management system, specifically lacking a required FMEA for its Class II GlutenID Genetic Health Risk Test. Additionally, controls over outsourced processes for assembling and distributing genetic testing kits were not proportionate to the risk, with inadequate supplier qualification and monitoring procedures for a critical supplier.