Federal regulators warned months ago of potential problems at a baby food factory, according to documents and a public timeline of events, raising the question of whether the government could have done more sooner to address operational issues and avoid a nationwide shortage.
Food and Drug Administration inspection reports, as well as a 34-page whistleblower report from a former Abbott Laboratories employee, suggest the FDA was first notified last fall of suspected plumbing problems at an Abbott facility in Sturgis, Michigan. But it wasn’t until mid-February, after the agency discovered deadly bacteria at the plant, that Abbott issued a voluntary recall — a drastic measure that outsold a significant portion of the country’s stock.
Months later, there are still concerns about how long it will take to get the facility back up and running safely as families struggle to access formula.
“We know there are 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 an assessment and, as outlined in our recently released Plan To improve response to food outbreaks, we will build performance metrics into the FDA’s food program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities.”
For his part, Abbott said it has been working to resolve the concerns of the FDA and, subject to federal approval, could resume operations at the Michigan plant in two weeks.
Abbott says there is no evidence that its products contributed to the two infant deaths.
“We are confident that we can continue to produce safe, high-quality infant formulas in all our facilities, as we have for decades for millions of babies around the world,” the company said.
Here’s what you need to know about the agency’s investigation timeline.
September 2019: The FDA conducts an inspection of the Sturgis plant, with one violation in testing.
September 20, 2021: The FDA conducts a factory inspection, noting that personnel working directly with formula do not properly wash their hands when necessary and do not change gloves after touching “non-food” contact surfaces.
“You have not kept a building used for the production, processing, packaging or storage of infant formula clean and hygienic,” the FDA concluded in its September 2021 report.
On the same day that FDA inspectors are at the Sturgis plant, the Minnesota Department of Health warns the agency that a baby had become ill with a bacteria called Cronobacter sakazakii after drinking formula produced at the Sturgis plant. However, researchers later found no substantive link between the plant’s formula and the child’s illness.
October 20, 2021: In a 34-page document, a factory whistleblower alleges that Abbott released untested infant formula, hid information during previous FDA audits, and imposed lax cleaning practices. None of these claims have been independently verified. According to Representative Rosa DeLauro, a Connecticut Democrat, who later released the whistleblower report, the FDA will be interviewing that person in late December.
Feb. 1, 2022: The FDA collects samples at the plant confirming the presence of the dangerous Cronobacter bacteria and cites several violations, according to an inspection report.
February 17, 2022: The FDA says it is investigating reports of four illnesses in three states, including a dead baby. Abbott announces a voluntary recall of potentially affected products, including Similac, Alimentum and EleCare powdered formulas manufactured at the Sturgis facility.
February 28, 2022: The FDA announces a second death and Abbott extends its recall.
Sony Salzman of ABC News contributed to this report.