FDA 483 - Nat2 Inc - May 20, 2024

Nat2 Inc, an infant formula manufacturer in Heath, OH, was cited for six observations related to significant deficiencies in their manufacturing processes. The inspection revealed critical issues including inadequate environmental monitoring and remediation for microbial contamination, poor equipment cleaning and maintenance, and failures in both microbiological and nutrient testing of finished products and water. These conditions indicate a high potential for product adulteration and non-compliance with infant formula regulations.