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Abbott strikes deal with FDA to reopen baby formula factory to ease nationwide shortages

A woman purchases infant formula at Target in Annapolis, Maryland, on May 16, 2022, as nationwide shortages of infant formula continue due to a breakdown in the ocean-related supply chain. The coronavirus outbreak has strained formula stocks in the country, a problem exacerbated by a major product recall in February.

Jim Watson | AFP | beautiful pictures

Abbott has reached an agreement with the Food and Drug Administration to reopen its manufacturing plant in Michigan to help alleviate a nationwide shortage of infant formula, the company announced Monday.

Abbott said it could restart the Michigan plant within two weeks with FDA approval. However, it will take six to eight weeks from the start of production for the formula to hit store shelves, according to the company. The agreement between Abbott and the FDA, known as a consent decree, must be approved by the court.

“This is an important step towards the reopening of our Sturgis facility so we can alleviate the formula shortage across the country,” said Abbott CEO Robert Ford. “We look forward to working with the FDA to reopen the facility quickly and safely.”

Mothers are having a hard time finding formula for their babies as it’s empty in many stores across the US More than 40% of baby formula sold out of stock in the US in the week ending May 8th. 5, according to Datasembly, a company that tracks retail data.

White House press secretary Karine Jean-Pierre told reporters Monday that the Biden administration is also taking steps to import infant formula from other countries. The United States produces 98% of the infant formula it consumes. The FDA will allow foreign companies to register to supply infant formula to the US market with approval in accordance with the safety standards of the drug regulator.

“We have alerted embassies, retailers and manufacturers to identify potential companies that will use the new FDA import process,” said Jean-Pierre.

The shortfall was partly due to the closure of Abbott Nutrition’s manufacturing plant in Michigan after four infants fed formula from the facility fell ill with a bacterial infection, two of which later died. Abbott is the largest manufacturer of infant formula in the US

FDA inspections discovered the presence of Cronobacter sakazakii, a bacteria that can cause blood infections, at the Sturgis, Mich. plant. Abbott’s internal records also show that the company destroyed some of its products due to the presence of bacteria at the plant, according to the FDA.

In February, Abbott issued a voluntary recall of Similac PM 60/40, Similac, Alimentum and EleCare products manufactured at the Michigan plant. Abbott said last week that none of the infant formula distributed to consumers from the Sturgis plant had tested positive for the bacteria, and that the genetic sequencing of two samples from the sick infant did not match the strain of Cronobacter. found in the factory.

The FDA ended the inspection in March. The Centers for Disease Control and Prevention found no additional cases of infants infected with Cronobacter after consuming products from the Michigan facility.

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