OIG Launches Audit on FDA Over Response to Baby Formula Shortage

Baby Formula Shortage baby formula Office of Inspector General Food and Drug Administration FDA OIG Abbott Abbott Nutrition FDA Audit

By Joel Brussels , Parent Herald Jun 04, 03:21 pm

Photo: (Photo : Justin Sullivan/Getty Images)

The Health and Human Services' Office of Inspector General (OIG) is launching an audit into how the U.S. Food and Drug Administration (FDA) responded leading up to the massive February recall of baby formula and closure of Abbott Nutrition's facility in Sturgis, Michigan.

OIG's review, which was first reported by ABC News, will examine whether the FDA upheld its duty "to safeguard the nation's food supply, including infant formula and ensure all ingredients are safe" and if the federal agency's regulators followed proper recall protocol once a deadly bacteria had been detected inside the Michigan plant of Abbott.

Abbott's Sturgis facility was shut down back in mid-February after contamination issues inside the plant had been linked to four infants being hospitalized with a rare but serious bacterial infection, two of whom ultimately passed away.

Abbott's quality control has come under questioning before

The review of the actions of the FDA marks an uncommon and extraordinary move from the watchdog agency. The OIG's advent also punctuates frustrated and loud calls from lawmakers and the American public alike for accountability on the ongoing baby formula shortage - a now-nationwide crisis which was made worse by Abbott's contamination issues and ultimate shutdown.

This is not the first time that Abbott's quality control has come under questioning. According to documents and a public timeline of the events, federal regulators warned months ago of potential problems at a manufacturing plant for infant formula.

The FDA found sanitation issues at the Sturgis plant in September 2021, according to the New York Post. Abbott "did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition," according to the agency's inspection report.

FDA had collected samples at the plant by February 1 which confirmed the presence of cronobacter, according to the report. Abbott maintains, however, that there is no conclusive evidence that its formula products contributed to the death of the two infants.

Agency leaders failed to act on whistleblower report

But it was not until the middle of February when Abbott, the largest infant formula manufacturer in the United States, issued a voluntary recall. The drastic move by Abbott quickly slashed a significant share of the formula supply in the U.S. - a market which had already started to show signs of strain from supply chain disruptions brought upon by the COVID pandemic.

There was also a 34-page whistleblower report from a former employee of Abbott Laboratories, who alleged a "litany of violations" and contamination issues at the company's Sturgis plant. That complaint remained in limbo for months, though, after it was sent to the FDA in October 2021, according to Politico.

Agency leaders recently testified before members of the U.S. Congress, saying that they did not receive that report last fall "due to an isolated failure in FDA's mailroom, likely due to COVID-19 staffing issues."