Months after it stopped production and recalled its products, worsening a pandemic formula shortage, baby formula maker Abbott has entered into a consent decree with the U.S. Food and Drug Administration, making way for the pharmaceutical company to reopen its infant formula plant in Michigan, Abbott announced Monday.
Once the FDA confirms the initial requirements have been met, it could restart the site in southwest Michigan within two weeks, Abbott reported in a statement.
It would begin producing EleCare, Alimentum and metabolic formulas first and then start making Similac and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” Robert B. Ford, chairman and chief executive officer, said in the statement.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
The baby formula 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, Mich. plant. 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.
“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan. The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve,” said FDA Commissioner Robert M. Califf, M.D.
“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. 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.”
In the meantime, the FDA is also continuing to implement several important steps to improve the supply of infant and specialty formula products in the U.S. The agency has been in ongoing discussions with all infant formula manufacturers who are reporting that they are all producing at an expanded capacity.