The investigation was launched less than a month after Abbott received FDA approval to reopen its Sturgis, Michigan, manufacturing.
The factory is the biggest producer of infant formula in the country.
Following a bacterium contamination in four newborns, two of whom died, the institution was shut down in February.
According to the investigation, it was unlikely that the illnesses in the earlier cases were caused by Abbott products.
After strong thunderstorms and torrential rains damaged the facility, the Sturgis plant was shut down once more more than a week ago.
Before reopening, the corporation claimed it requires time to evaluate the damage and re-sanitize the factory.
Meanwhile, there is still a severe scarcity of infant formula in the United States.
About 16 million 8-ounce baby formula bottles will be imported from Mexico starting this weekend, according to a statement released on Wednesday by the Biden administration.
The action is a part of President Joe Biden’s Operation Fly Formula campaign, which aims to ease supply difficulties made worse by the Abbott facility closure.
According to a consumer complaint delivered to the FDA on June 10, the most recent newborn mortality happened in January.
The FDA made note that its inquiry is still in the early stages but did not disclose which Abbott product the youngster was believed to have taken or where the infant formula was made.
A representative for Abbott told DailyMail.com on Wednesday that the business was made aware of the newborn fatality case the previous week.
The producer of the formula, however, asserts that “little product and clinical information required to evaluate the case” was given.
According to the spokesman, “At this time, there are no inferences that can be made and no evidence to establish a causal association between Abbott’s formulae and this reported case.”
If more information becomes available, we will look into the matter further in accordance with our complaint processing procedure.
Following many complaints of newborn mortality, Abbott issued a recall for formula in February 2022.
Between December 2021 and March 2022, the FDA looked into nine complaints of child deaths that were purportedly related to baby formula, including seven that had not before been made public. The latest incident would be the tenth reported death.
A list of 128 customer complaints sent to the FDA contained the claims of newborn deaths. On June 8, eFoodAlert made the allegations widely known.
The four confirmed cases of Cronobacter sakazakii found by the Centers for Disease Control and Prevention included two of the deaths cited in the complaints (CDC).
Cronobacter germs were allegedly found at the Sturgis factory by the FDA.
The FDA and Abbott conducted a “thorough investigation,” according to an Abbott spokesman, and found that “infant formula produced at our Sturgis site is not the likely source of infection in the reported instances” and “there was not an outbreak caused by goods from the facility.”
Two of the other seven deaths that were reported to the FDA’s consumer complaint system specifically identified Salmonella.
According to the FDA, there is insufficient evidence to conclusively link these seven events to Abbott’s plant.
Government officials are working to alleviate the nationwide baby formula shortfall, which grew worse when the Abbott factory closed in February.
Similac was one of many popular formula brands that Abbott recalled at the time. Due to stockpiling during the COVID-19 shutdowns and supply chain interruptions, stocks were already under pressure.
Children who depend on specialized formulas and have allergies, gastrointestinal issues, or metabolic diseases have been particularly badly affected by the prolonged formula scarcity.
The Biden administration said on Wednesday that this coming weekend, baby formula will be imported from Mexico.
The volume of Gerber Good Start Gentle infant formula that will be transported by trucks from a Nestlé facility to stores in the United States will nearly double, according to the Department of Health and Human Services’ (HHS) expedited shipping program.
Baby formula has already been imported into the United States via cargo flights from Europe and Australia, including two additional air shipments that start this weekend.
The Food and Drug Administration took action last month to relax federal import restrictions so that baby formula may be transported to the United States.
Additionally, Biden approved the use of the Defense Production Act to give federal funding for the importation of formula from abroad.
In a statement released on Wednesday, FDA Commissioner Robert M. Califf said, “The FDA is working day and night to ensure that parents and caregivers can easily acquire safe and nutritious formula products for every child who requires them.”
“I have personally spoken with infant formula producers over the past several weeks and all have greatly improved their production efforts, resulting in more supply that will be available on shop shelves going forward,” the company said.
According to Califf, the FDA started importing 365 million full-size, 8-ounce bottles of infant formula, or roughly 17 million cans, over the past month.
The agency claimed that more formula will be added to shop shelves in the upcoming weeks and months and that the products have “already started to penetrate the U.S. market.”
“Consumers should have confidence that the infant formula that is being imported to the U.S. through this process involved a thorough review of the information provided by the companies,” the FDA said in a statement.
“This review included details about the product’s nutritional adequacy and safety, microbiological testing results, labeling information, and importantly, details about the manufacturing facility’s food safety production practices and inspection history.”