FDA 483 - ABBOTT IRELAND LIMITED - March 14, 2025

Abbott Ireland, an infant formula manufacturer in Cootchill, Cavan, was cited for significant deficiencies in its process controls, leading to the adulteration of infant formula with Cronobacter sakazakii. The inspection revealed finished product positives, widespread environmental contamination, numerous water events in high-care areas, and inadequate hygienic zoning controls, indicating a severe breakdown in sanitation and pathogen prevention systems.