FDA 483 - Abbott Laboratories - December 16, 2022

An FDA inspection of Abbott Laboratories dba Abbott Nutrition in Sturgis, MI, an infant formula manufacturer, revealed significant deficiencies in process controls, personnel hygiene, and facility sanitation. Inspectors noted a failure to adequately address water leaks and microbial contamination risks, improper gowning practices by employees, and unsanitary conditions including insects and debris. Additionally, the firm did not adhere to its own procedures for timely investigation and closure of serious adverse event consumer complaints, some of which involved Salmonella and death.