Upon receiving the FDA approval, which is subject to meeting the initial requirements for start-up, Abbott can restart the production at the facility within two weeks
Abbott Nutrition’s SIMILAC product. (Credit: Abbott)
Abbott has signed a consent decree with the US Food and Drug Administration (FDA) to restart the production of infant formula at its facility in Sturgis, Michigan.
The consent decree is an agreement between the Abbott and the US FDA, on steps required to resume production at the plant, and is subject to court approval.
Under the proposed decree, Abbott will take corrective actions, including a review of its operations at the Sturgis facility, by an independent expert.
The company is obligated to implement a sanitation plan, environmental monitoring plan, employee training programmes and testing of products.
Also, it is required to stop production and notify the FDA in case of any contamination detected.
Abbott chairman and chief executive officer Robert Ford said: “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. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
In February this year, the healthcare company voluntarily recalled some of its baby formulas after complaints related to bacterial infections and has stopped production at the Michigan plant.
Simultaneously, the US agency advised consumers not to use certain powdered infant formula products produced at the infant formula production facility in Michigan.
The evidence of Cronobacter sakazakii was found in the facility’s non-product contact areas during the testing, which is a commonly found bacterial contaminant.
The US FDA, together with the US Centers for Disease Control and Prevention (CDC), has been investigating consumer complaints regarding infections.
Upon receiving the FDA approval, which is subject to meeting the initial requirements for start-up, Abbott can restart the production at the facility within two weeks.
The company intends to initially re-start the production of EleCare, Alimentum and metabolic formulas, with plans to produce Similac and other formulas subsequently.
It may require six to eight weeks from the start-up to bring the products to the shelves.
Abbott is a large-scale supplier of infant formula in the US, and the shut-down of the Michigan facility has led to a shortage of the product across the country, reported Reuters.
The current move forms an important step towards resolving the shortage of baby formula across the US, said the publication.