In the United States, infections in infants are thought to be caused by infant formula.
Riley San Miguel, one of those who had the infection, said that her son, Kru, cried often, was one month old and did not want to eat. When the baby's fever rose, he was quickly admitted to the intensive care unit. Bacteria had infected his spinal fluid and was spreading to his brain. Doctors believed it was probably caused by baby food.
"At the beginning, doctors were worried about Kru's life," said Ms. San Miguel, 23, who lives in Sonora, Texas.
The baby had the first of multiple surgeries to control his increasing seizures and brain growth. Even when he could not breathe on his own, he lived on a ventilator for 21 days.
Eventually, most of the right side of his brain had to be removed.
He learned that his son had been exposed to Cronobacter sakazakii, a deadly bacterium often associated with infants consuming powdered formula, which can cause severe brain damage, developmental disabilities and death.
Department of Health officials analyzed two open-box formulas found at Ms. San Miguel's home. But they were two products, one negative and the other not having enough product to test the other.
Kru fell ill in August 2019, nearly two years before the date of similar infections in four infants, two of whom were fatal.
Abbott Stugis, one of the baby food manufacturers, had also recalled the last products consumed by sick babies, produced in the Michigan factory, 2 years ago, with a recall campaign.
The recall has also led to a shortage of baby food, the product parents use to feed their children.
The Biden management held talks with Abbott to restart production and secure additional supplies from Europe.
As with Kru's disease, infections in the last four sick infants could not be linked to production at any Abbott Nutrition facility.
But while much of the attention has been focused on tackling the dire supply gap, regulators also face continuing deeper safety issues in powdered infant formula production.
There is no comprehensive mechanism for detecting or investigating Cronobacter infections.
In order to continue research, the state of Minnesota requires doctors and laboratories to report cases to authorities.
Manufacturers have to run tests on a relatively small sample of their production.
Less than 1 percent of the Abbott facility's total output needs to be tested. The combination of blind spots makes it difficult to trace infections back to their source. This may place families at risk of future isolation and infant mortality.
The Sturgis plant had problems until 2010, when the insect parts in the formula triggered another recall.
In recent years, federal inspectors have been reporting stagnant water in production areas, a fan filled with dust and debris near a formula drying area, and uninsulated sanitary areas, according to inspection reports.
In October, a whistleblower complaint from a former Sturgis quality assurance worker came to the Food and Drug Administration.
In 2019, the factory also claimed that it did not destroy an entire line of formulas with problematic microorganisms.
Because “top management was under significant pressure to meet the 'production figures'”. The company was eliminating the detail files on the microorganisms the inspectors had found before giving it to the FDA.
No samples of Cronobacter from the four sick babies matched those found at the Sturgis factory, Abbott said.
The company reported that an open container of formula consumed by one of the infants tested positive for two Cronobacter genetic variants, but these variants also did not match those found at the facility.
He said one matched a sample found in a water bottle used to mix the formula.
"The formula from this factory did not cause these infant illnesses," the company said.
Abbott said the former employee who filed the whistleblower complaint was fired for violating food safety policies and has since made "evolving, new and escalating" allegations.
The company said it expects to address all of the FBI's concerns when it reopens the Sturgis factory in the next two weeks.
A consent decree the company has signed with the government will provide a host of new safeguards, including hiring a qualified specialist to oversee improvements at the factory and notifying the FDA if any contamination is detected.
Cronobacter and salmonella samples found should also be stored for three years.
“We are confident we can continue to produce safe, high-quality infant formula across all our facilities, as we have done for millions of babies around the world for decades,” said Abbott.
The lack of testing and public reporting makes it difficult to know how many people are infected with Cronobacter.
An official from the Federal Centers for Disease Control and Prevention, Dr. According to Julia Haston, one study estimates about 18 cases per year in US infants.
The results are often severe, and up to 40 percent of babies who go on to get bacterial meningitis, a common complication, die from the infection, he said.