The FDA lacked or had inadequate policies in place to identify risks to the infant formula supply chain when it received complaints about production at a plant in Sturgis, Michigan, said an inspector general’s report on Thursday. Months passed before the FDA warned consumers in February 2022 not to use some of the products made at the Abbott Laboratories plant, leading to a formula shortage.
“FDA should improve its inspection and recall processes to better ensure the safety of the infant formula supply,” said the inspector general of the Department of Health and Human Services. The report recommended nine improvements and said the FDA concurred with them.
Connecticut Rep. Rosa DeLauro, who requested the report, said she would file legislation “to strengthen FDA’s regulatory authority so we can prevent a [formula] shortage like this from potentially happening again.” The report said it had taken the FDA 15 months to inspect the Sturgis plant after receiving a whistleblower complaint. “Based on the OIG’s report, the FDA did not move quickly enough to address very credible allegations of lax safety practices and cut corners at the Abbott plant in Sturgis, Michigan, that spurred the infant formula shortage,” said DeLauro.
The FDA’s slow response to the situation at the Sturgis plant was a factor leading to the reorganization of the agency’s food safety wing in 2023.
The inspector general’s report is available here.