Abbott Nutrition has restarted production at the Michigan baby formula factory that has been closed for months due to contamination, taking a step toward easing a nationwide supply shortage expected to persist into the summer
in February after the Food and Drug Administration began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died. The company continues to state that its products have not been directly linked to the infections, which involved different bacterial strains.
FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols. The FDA has faced intense scrutiny for taking months to close the plant and then negotiate its reopening. Agency leaders recently told Congress they had to enter a legally binding agreement with Abbott to assure all the problems were fixed.
Abbott is one of just four companies that produce about 90% of U.S. formula. The company’s recalls and shutdown triggered a cascade of effects: Retailers have limited customer purchasing to conserve supplies and parents have been told to switch brands to whatever formula is in stock.it could be about two months before formula supplies return to normal levels. The agency has waived many of its regulatory requirements to accept more formula from the United Kingdom, Australia and other nations.
U.S. manufacturers, including Reckitt and Gerber, have also stepped up production, running plants 24/7 and sourcing more formula from alternate facilities.
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