The FDA was aware for months of potential problems at the Abbott manufacturing plant for baby formula before it sounded the alarms for parents.
Federal regulators warned months ago of potential problems at a manufacturing plant for baby formula, according to documents and a public timeline of the events, raising questions about whether more could have been done sooner by the government to address operational issues and prevent a nationwide shortage.
Inspection reports by the Food and Drug Administration, as well as a 34-page whistleblower report from a former employee of Abbott Laboratories, suggest the FDA first became aware last fall of suspected sanitation issues at an Abbott facility in Sturgis, Michigan. But it wasn’t until mid-February after the agency detected deadly bacteria inside the plant, that Abbott issued a voluntary recall – a drastic move that syphoned off a significant portion of the nation’s supply.
Months after that, concerns still remain about what is taking so long to get the facility running again safely, as families scramble for access to formula.
"We know there have been questions about the timeline," the FDA said in a statement released Friday. "However, this remains an open investigation with many moving parts. We are continuing to investigate and will continue to update you as information becomes available. Once the immediate risk to the public has been addressed, we will conduct a review and, as outlined in our recently released Foodborne Outbreak Response Improvement Plan, we will build in performance measures across the FDA's foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities."