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

Mead Johnson Nutrition's Evansville, IN facility was inspected by the FDA from August 23-26, 2021, under programs governing infant formula, medical foods, and general food safety. The inspection focused on the manufacturing of powder and liquid infant formula and medical food products. The inspection resulted in a 3-point FDA Form 483, detailing critical observations. These included a temperature-indicating device not being accurately or easily readable, failure to record a critical factor specified in the scheduled process, and insufficient frequency in recording operating conditions necessary for achieving commercial sterility. Further discussions with management revealed concerns such as grouped operational checks hindering verification of bleeder function, an obstructed bleeder, and inadequate monitoring of water conditions in cooling systems. The firm also lacked identified ranges for certain operational parameters on production records and failed to re-sample individual sites after a positive Cronobacter environmental finding to isolate the source. These findings highlight deficiencies in critical process control and documentation, requiring prompt and comprehensive corrective actions. The company must implement changes to ensure full compliance with FDA regulations, addressing the identified "Not Corrected" status of the observations to safeguard product quality and consumer safety.