>Abbott Labs
Abbott Labs, FDA reach deal on reopening shuttered baby formula factory
Abbott Laboratories, whose recall of infant formulas made at a Michigan plant has been widely blamed for a nationwide shortage, announced Monday it had reached an agreement with the Food and Drug Administration on the steps needed to restart production — but it will still be weeks before any formula hits store shelves.
Abbott also claimed in its announcement that the Centers for Disease Control and Prevention had found no “conclusive evidence” linking formulas made at its Sturgis, Mich. facility to the infant illnesses and deaths that triggered the initial recall in February.
Once a court signs off on the deal and the FDA gives the go-ahead to reopen the problem-plagued facility, Abbott could restart formula production within two weeks — though it will still be six to eight weeks before its products become publicly available.
Details of the agreement, known as a consent decree, were not immediately disclosed.
“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,” Abbott chairman and CEO Robert B. Ford said in a 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.”
By Gabrielle Fonrouge
May 16, 2022
https://nypost.com/2022/05/16/abbott-labs-fda-reach-deal-on-reopening-baby-formula-factory/
https://www.abbott.com/