On May 16, 2022, a woman purchased infant formula at Target in Annapolis, Maryland. This is due to the continuing national shortage of infant formula due to the supply chain crisis associated with the coronavirus pandemic, which is already squeezing the country’s infant formula inventory. It was exacerbated by the recall of a major product in February.
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Abbott The company announced on Monday that it had reached an agreement with the Food and Drug Administration to reopen its manufacturing plant in Michigan to alleviate the national shortage of infant formula.
Abbott said the Michigan plant could be reopened within two weeks, subject to FDA approval. However, according to the company, it will take six to eight weeks from the start of production for the formula to hit the shelves. The agreement between Abbott and the FDA, called the Consent Decree, requires court approval.
“This is a big step towards reopening the Sturges facility and can alleviate the nationwide shortage of infant formula,” said Abbott CEO Robert Ford. “We look forward to working with the FDA to reopen the facility quickly and safely.”
According to Datasembly, which tracks retail data, mothers are having a hard time finding infant formula with empty shelves in many stores across the United States. By the week leading up to May 8, more than 40% of infant formula was out of stock in the United States.
The Biden administration is also taking steps to import infant formula from other countries, White House spokesman Karine Jean-Pierre told reporters Monday. The United States produces 98% of the powdered milk it consumes. The FDA permits foreign companies to apply for powdered milk supply to the US market with approval in accordance with the safety standards of drug regulators.
“We warned embassies, retailers and manufacturers to identify companies that may take advantage of the new FDA import process,” said Jean-Pierre.
The supply shortage was partially caused by the closure of the Abbott Nutrition manufacturing plant in Michigan after four infants who consumed formula from the facility became ill with a bacterial infection, two of whom subsequently died. It was done.Abbott is the largest infant formula manufacturer in the United States
An FDA test found the presence of Cronobacter Sakazaki, a bacterium that can cause blood infections, at a factory in Sturgis, Michigan. According to the FDA, Abbott’s internal records also show that the company destroyed some of its products due to the presence of bacteria in the factory.
According to the Department of Justice, under a consent decree to reopen the factory, Abbott will need to retain the support of outside experts to make the facility compliant with federal regulations. External experts design Abbott’s plans to reduce the risk of bacterial contamination in the plant and carry out regular assessments to ensure that the company is in compliance. This is done under the supervision of the FDA.
In February, Abbott announced the voluntary recovery of Similac PM 60/40, Similac, Alimentum, and EleCare products manufactured at the Michigan plant. Abbott’s milk powder distributed to consumers from the Sturges plant last week was not tested positive for bacteria, and the genetic sequences of two samples from sick infants are one with the Cronobacter strain found in the plant. He said he didn’t.
The FDA completed the inspection in March. The Centers for Disease Control and Prevention have not found additional cases of infants infected with Cronobacter after consuming the product from a facility in Michigan.