FDA 483 - Magno-Humphries Inc. - August 06, 2025

An FDA inspection of Magno-Humphries Inc., an OTC Drug Repacker/Relabeler in Tigard, OR, revealed a significant quality control deficiency. The firm's quality unit failed to consistently perform required in-process quality inspections, specifically not obtaining random packaged containers three times during the packaging process as mandated by their own sampling SOP. This indicates a breakdown in adherence to established quality control procedures.