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Abbott reaches agreement with FDA to reopen baby formula plant to ease nationwide shortage

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On May 16th, 2022, a woman shop at Target Annapolis for baby formula. This is due to a national shortage.

Jim Watson | AFP | Getty Images

AbbottOn Monday, the company revealed that they had reached an agreement to allow its Michigan plant to reopen to the Food and Drug Administration in order to alleviate a national shortage of baby formula.

Abbott claimed it is able to restart the Michigan factory within two weeks. This was subject to FDA approval. The company stated that formula would be on the shelves within six to eight week after it began production. A consent decree is an agreement between Abbott, FDA and other parties. It must be approved by the court.

A nationwide shortage has caused many supermarket shelves to be empty, leaving mothers struggling to find the right formula for their babies. Datasembly (a company that monitors retail data) reports that more than 40% of the U.S. stock of formula for infants was unavailable in the week ended May 8.

After four children who had received formula from Abbott Nutrition in Michigan fell ill with bacterial infections and two died, the closing of the Abbott Nutrition manufacturing plant in Michigan caused a shortage in supply. Abbott is America’s largest manufacturer of infant formula.

The presence of Cronobacter Sakazakii at Sturgis, Mich., was discovered by inspections conducted by the Food and Drug Administration. This bacteria can lead to blood infections. According to the FDA, internal records at Abbott also revealed that some products were destroyed by the bacteria.

Abbott announced a voluntary recall in February of Similac PM 60/40 and Similac, Alimentum, and EleCare products manufactured at its Michigan facility. Abbott claimed last week, that consumers of formula from Sturgis were not tested for the bacteria and the genetic sequencing from two infants with severe illnesses did not confirm the presence of Cronobacter.

In March, the FDA completed its inspection. After consuming Cronobacter products at the Michigan facility, no infants were infected by it again according to the Centers for Disease Control and Prevention.

This story is breaking. Keep checking back for more updates.

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