Baby formula manufacturer Abbott and the Food and Drug Administration agreed Monday on a consent decree outlining the steps necessary to resume production at the company’s Sturgis, Mich., plant, which shut down due to safety issues earlier this year.
The decree, which mandates the specific measures the company must take to increase safety and ensure compliance with federal law, needs court approval to move forward, and it could be at least two months before formula produced at the plant is available.
“Parents who feed their babies formula must have confidence these products are safe,” U.S. Atty. Mark Totten for the Western District of Michigan said in a statement. “This proposed consent decree aims to protect one of our most vulnerable populations.”
Once the court accepts the decree and the FDA determines that the steps necessary to restart the plant have been met, Abbott could resume production at the site within two weeks. It would take an additional six to eight weeks before the formula produced would be available on shelves.
According to an Abbott news release, the facility would first focus on producing the hypoallergenic formulas EleCare, Alimentum and metabolic formulas first, and then begin production of Similac and other formulas.
The company will also continue to import formula from an FDA-registered facility in Ireland to help alleviate near-term supply shortage, according to the release. The FDA is expected to make an announcement soon about making it easier to import formula from facilities it has approved in other countries.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward reopening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely reopen the facility,” Robert B. Ford, Abbott’s chairman and chief executive, 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.”
The plant has been shuttered since February, after several babies who consumed formula that was produced there fell ill and two infants died.
During an inspection of the plant, the FDA discovered a deadly bacteria, cronobacter, in and near production lines. The bacteria can live in dry foods, such as powdered formulas, and can cause deadly sepsis or meningitis in infants. Abbott has emphasized that its products have not been directly linked to the bacterial infections in children, and the FDA investigation did not find the bacteria in formula at the plant.
The closure included a recall of several popular types of formula as well as hypoallergenic formulas for which there are few alternatives, exacerbating existing supply chain issues and reducing or eliminating stockpiles parents had built.
The resulting nationwide infant formula shortage has left some families scrambling to feed their children.
Source by www.latimes.com