Abbott has reached an agreement with the Food and Drug Administration to reopen its manufacturing plant in Michigan to help ease a nationwide shortage of baby formula, the company announced Monday.
Abbott said it can restart Sturgis, Michigan, plant within two weeks subject to a court approval. However, it would take six to eight weeks from the start of production for formula to arrive on store shelves, according to the company.
The agreement between Abbott and the FDA, called a consent decree, is subject to approval by the U.S. District Court for the Western District of Michigan.
“This is a major step toward reopening our Sturgis facility so we can ease the nationwide formula shortage,” Abbott CEO Robert Ford said. “We look forward to working with the FDA to quickly and safely reopen the facility.”
Mothers are struggling to find formula for their infants with shelves empty in many stores across the U.S. More than 40% of baby formula was out of stock in the U.S. during the week ended May 8, according to Datasembly, a retail data tracker.
The Biden administration is also taking steps to import baby formula from other countries, White House press secretary Karine Jean-Pierre told reporters Monday. The nation produces 98% of the baby formula that U.S. consumers buy. The FDA will allow foreign companies to apply to supply baby formula to the U.S. market with approval subject to the drug regulator’s safety standards.
“We have alerted embassies, retailers and manufacturers to identify potential companies that would make use of the new FDA importation process,” Jean-Pierre said.
The supply shortage was triggered in part by the closure of Abbott Nutrition’s manufacturing plant in Michigan after four infants who consumed formula from the facility fell ill from bacterial infections, two of whom subsequently died. Abbott is the largest infant formula manufacturer in the U.S.
Inspections by the FDA found the presence of Cronobacter sakazakii, a bacteria that can cause blood infection, at the Sturgis factory. Abbott internal records also showed that the company destroyed some of its product due to the presence of the bacteria at the plant, according to the FDA.
Under the consent decree to reopen the plant, Abbott will have to retain outside expert assistance to bring the facility into compliance with federal regulations, according to the Justice Department. The outside experts will design plans for Abbott to reduce the risk of bacterial contamination at the plant and conduct periodic evaluations to make sure the company is in compliance. The process will be done under FDA supervision.
In February, Abbott issued a voluntary recall of its Similac PM 60/40, Similac, Alimentum and EleCare products made at the Michigan plant. Abbott said last week that no formula distributed to consumers from the Sturgis plant tested positive for the bacteria, and genetic sequencing of two samples from the sick infants did not match the Cronobacter strains found in the plant.
The FDA concluded its inspection in March. The Centers for Disease Control and Prevention has found no additional cases of infants infected with Cronobacter after consuming products from the Michigan facility.