Outdated Equipment and Invalidated Safety Protocols
A Broken Clean-In-Place System
States say Abbott leaned on unvalidated dry-out procedures—a critical step in sanitation—through late 2022. Equipment at the Sturgis plant was “old and always in need of repair,” undermining safe production.
Before 2022, Abbott allegedly tested its environment only after surfaces had been cleaned, effectively defeating the purpose of microbial monitoring. Once FDA conducted its own tests, employees noted a sharp rise in contamination indicators.
The FDA also found Abbott failed to follow its own complaint procedures, often closing cases without identifying root causes of infant illnesses.
No Comment From Abbott
Neither Abbott nor the attorneys for the states immediately responded to requests for comment Tuesday.
Counsel for Abbott has not yet been disclosed.
