FDA 483 - CANADA ROYAL MILK ULC - August 15, 2025

An FDA inspection of CANADA ROYAL MILK, an infant formula manufacturer in Kingston, Ontario, revealed significant deficiencies in its process control system. The firm failed to adequately monitor its production environment for microorganisms, leading to positive findings for Cronobacter sakazakii in both product and environmental samples. Additionally, the company's procedures for corrective actions and investigations into contamination events and facility issues like roof leaks were found to be inadequate.