FDA 483 - Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. - July 22, 2022

An FDA inspection of Mead Johnson & Company, an infant formula manufacturer in Ciudad Delicias, Mexico, revealed a significant lapse in temperature monitoring for thermal processing equipment. Specifically, the firm failed to adequately monitor and document HTST pasteurizer temperatures, a critical control point for infant formula base preparation. This indicates a potential risk to product quality and safety due to inadequate process control.