The baby formula shortage in the United States has led to an investigation of the Food and Drug Administration (FDA). The Health and Human Services Office of Inspector Geneal will begin to audit actions by the FDA beginning “with a September 2021 report of contamination and ended with a massive  February recall of infant formula” reports the Western Journal. 

There is a documented five-month gap between the original contamination findings and the Food and Drug Administration’s action to close the Abbott Nutrition plant in Sturgis, Michigan.

The audit will investigate whether the FDA proceeded properly once the contamination was discovered, and to “safeguard the nation’s food supply, including infant formula and ensure all ingredients are safe” reported ABC. 

President Biden defended the FDA’s actions at the White House Wednesday: “Well, I don’t think anyone anticipated the impact of the shutdown of one facility in — the Abbott facility.  And it was accurately shut down because it was — the formula was questioned, in terms of its purity. And so, once we learned of the extent of it and how broad it was, we kicked everything into gear.”

Contradicting himself, he also stated that he became aware of the problem in April, an entire month before invoking the Defense Production Act to increase formula production. So in fact he did not kick everything into gear “once we learned of the extent of it and how broad it was.”

Biden was then asked by a reporter if during a meeting with CEOs, “didn’t those CEOs just tell you that they understood it would have a very big impact?”

“They did, but I didn’t,” Biden replied.

Biden then said that “the real problem occurred when it started — when it got shuttered.  So, you’re saying we — they should have anticipated it would be shuttered.”

An FDA report from September of 2021 said that the Sturgis plant “did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”

Shortly after, in October, a whistleblower came forward with a report which was “not ready by agency officials until February, according to Frank Yiannasm, the FDA’s deputy commissioner for food policy and response.” 

FDA officials blamed the pandemic and issues of processing mail for its delay. The New Yorker wrote the whistleblower’s report and allegations was “ghastly reading.” 

In the report, the whistleblower claimed every so often the plant “failed to properly seal cans of formula, and, as a work-around, performed safety tests on empty cans instead.” 

Additionally, poor equipment “caused product flowing through the pipes to pick up the bacteria that was trapped in the defective areas of the pipe” the report stated, adding that problems dated back as far as 2019 when formula at the plant tested positive for microorganisms that were supposed to be destroyed.