SensoryEffects Inc. – FDA 483, Mar 2, 2020

Sensory Effects Inc. in Faribault, MN, received three observations during an FDA inspection of its ready-to-eat food agglomerator facility. The inspection revealed critical deficiencies in personnel practices, including an employee contaminating food contact surfaces with unsanitized gloves. Additionally, the firm failed to implement adequate allergen and sanitation preventive controls, evidenced by unsanitized equipment and a long-standing unaddressed failed cleaning validation.