FDA 483 - Glanbia Nutritionals, Inc. - August 21, 2020

Glanbia Nutritionals Inc. in Springfield, MO, was inspected and received a Form 483 with three observations. The inspection revealed significant issues with the firm's hazard analysis and sanitation practices, particularly concerning the control of environmental pathogens like Cronobacter sakazakii in their Vivonex Pediatric Elemental Powder, a product for vulnerable infants. These deficiencies led to product contamination and inadequate preventive controls.