Abbott and the FDA
On Monday, Abbott announced that it has reached an agreement with the Food and Drug Administration to reopen its production unit in Michigan to help alleviate a statewide shortage of infant formula.
Abbott claims it can restart the Sturgis, Michigan, factory in two weeks if a court order is granted. The company estimates that it will take six to eight weeks from the commencement of production for the formula to reach shop shelves.
The consent decree between Abbott and the FDA must be approved by the United States government. The Western District of Michigan is a federal district court.
“This is a significant step toward restoring our Sturgis factory, which will help alleviate the nationwide formula shortfall,” stated Abbott CEO Robert Ford. “We look forward to working with the FDA to restart the facility soon and safely.”
In several stores around the United States, mothers are having difficulty finding infant formula. According to Datasembly, a retail data tracker, more than 40% of baby formula was out of supply in the United States for the week ending May 8.
According to White House press secretary Karine Jean-Pierre, the Biden administration is also looking into importing baby formula from other countries. The country produces 98 percent of the baby formula sold in the United States. The FDA will allow foreign companies to apply for approval to sell baby formula in the United States, subject to the drug regulator’s safety guidelines.
“We’ve notified embassies, shops, and manufacturers to identify companies that might employ the new FDA importation method,” Jean-Pierre explained.
The supply crisis was sparked in part by Abbott Nutrition’s closure of its Michigan manufacturing unit after four children who received the formula from the facility became ill with bacterial infections, two of whom died. Abbott is the world’s largest manufacturer of infant formula.
The presence of Cronobacter sakazakii, a bacteria that can cause a blood infection, was discovered during FDA inspections at the Sturgis facility. According to the FDA, Abbott’s internal records showed that the business destroyed some of its products owing to the presence of germs at the plant.
According to the Justice Department, Abbott will be required to hire outside experts to bring the plant into conformity with federal standards under the consent agreement. Outside experts will create strategies for Abbott to limit the danger of bacterial contamination at the plant, as well as conduct quarterly audits to ensure that the company is in compliance. The procedure will be monitored by the FDA.
Abbott voluntarily recalled Similac PM 60/40, Similac, Alimentum, and EleCare products made at the Michigan plant in February. Last week, Abbott announced that no formula from the Sturgis factory had tested positive for the bacterium and that the genetic sequencing of two samples from sick infants did not match Cronobacter strains detected in the plant.
In March, the FDA completed its examination. There have been no new occurrences of Cronobacter infection in infants after consuming goods from the Michigan factory, according to the CDC.