FDA 483 - Mead Johnson & Company, LLC - August 26, 2021

Mead Johnson Nutrition, an infant formula manufacturer in Evansville, IN, received a Form 483 with three observations. The inspection revealed issues with the accurate and easy readability of temperature-indicating devices, inadequate record-keeping for critical factors in the scheduled process, and insufficient frequency of recording operating conditions to ensure commercial sterility. These findings highlight deficiencies in process control and documentation for infant formula production.