The Office of Inspector General at the Department of Health and Human Services is conducting an investigation into how the Food and Drug Administration responded in the run-up to the massive recall of baby formula in February and the closure of Abbott Nutrition’s Sturgis plant.
The OIG’s investigation, first reported by ABC News, will look into whether the FDA upheld its duty “to safeguard the nation’s food supply, including infant formula, and ensure all ingredients are safe,” as well as whether FDA regulators followed proper recall protocol after a deadly bacteria was discovered inside the plant.
The plant in Sturgis, Michigan, was closed in mid-February after contamination issues were linked to four infants being hospitalized with a rare but serious bacterial infection, two of whom died. The FDA’s review of its actions is an extraordinary and unusual move by the watchdog agency.
Its arrival also underscores the American public’s and lawmakers’ frustrated calls for accountability on the ongoing infant formula shortage – a now-national supply crisis exacerbated by Abbott’s contamination issues and eventual shutdown.
This is not the first time Abbott’s quality control has been called into question.
According to documents and a public timeline of events, federal regulators warned of potential problems at a baby formula manufacturing plant months ago.
According to an inspection report, the FDA discovered sanitation issues at Abbott’s Sturgis plant in September 2021, saying it “did not maintain a building used in the manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition.”
According to an inspection report, by February 1, the FDA had collected samples at the plant confirming the presence of cronobacter. Abbott maintains that there is no conclusive evidence that its products were involved in the deaths of two infants.
But it wasn’t until mid-February that Abbott, the country’s largest infant formula manufacturer, issued a voluntary recall.
The drastic move quickly slashed a significant portion of the US formula supply – a market that was already showing signs of strain as a result of the pandemic supply chain disruptions.
A 34-page whistleblower report from a former Abbott Laboratories employee alleges a “litany of violations” and contamination issues at the Sturgis facility.
However, months passed after the FDA received the complaint in October 2021. Agency leaders recently testified in front of members of Congress that they did not receive the report last fall “due to an isolated failure in FDA’s mailroom, most likely due to COVID-19 staffing issues.”
According to FDA’s deputy commissioner for food policy and response, Frank Yiannas, the complaint was not seen by top officials until mid-February, nearly four months after it arrived at the agency.
As families continue to struggle to find food for their children, serious questions remain about whether a breakdown in the agency’s chain of command and communication aided a slow response to the growing problem. Some question whether the government could have done more to address sanitation and operational issues – and possibly avoid a nationwide shortage.
The findings of the OIG’s investigation are expected sometime in fiscal year 2024.