Abbott Nutrition would hire an outside expert and implement a sanitation plan at its infant formula plant in Michigan as part of returning the plant to production and ending U.S. shortages of formula, said the Justice Department on Monday. The largest U.S. maker of formula, Abbott has said it could resume production within two weeks once it has a federal go-ahead but it could take several weeks for products to reach retailers.
“The actions we are announcing today will help to safely increase the supply of baby formula for families,” said Attorney General Merrick Garland.
The proposed consent decree, which required approval by a federal judge, alleged that Abbott and three of its executives did not follow good manufacturing practices in producing powdered infant formula and spells out the steps to be taken to re-open operations. Abbott would retain an outside expert to help develop plans to reduce and control the risk of bacterial contamination of infant formula and periodically evaluate Abbott’s performance.
The plant has been closed since Feb. 17 and an FDA inspection identified at the facility a bacteria that can cause serve foodborne illness in infants. The FDA began its investigation after it received reports of illnesses among four infants, two of whom died. Abbott recalled some of the formula produced at the plant.
“We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation,” said FDA commissioner Robert Califf. “We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”
The White House said the FDA would issue new guidelines that would make it easier to import infant formula from other nations, reported Politico.