FDA 483 - Abbott Laboratories - November 01, 2022

An FDA inspection of Abbott Nutrition, Division of Abbott Laboratories in Columbus, OH, from October 19 to November 1, 2022, identified a critical issue with system maintenance. Specifically, a repaired capper component led to a reject system malfunction, failing to remove defective products from the line. This deficiency resulted in a voluntary recall of several 2oz Similac and Pedialyte products.