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Abbott Says Agreement Has Been Reached to Reopen Baby Formula Plant

Abbott Says Agreement Has Been Reached to Reopen Baby Formula Plant

Baby formula maker Abbott said Monday it has reached an agreement with U.S. health regulators to restart production at its largest domestic factory, though it will be well over a month before any new products ship from the site to help alleviate the national shortage facing parents.

The White House released a statement regarding the deal, saying a proposed consent decree of permanent injunction between the Food and Drug Administration (FDA) and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan. The FDA had been investigating safety concerns at Abbott’s Sturgis, Michigan, plant since early this year. The consent decree amounts to a legally binding agreement between the FDA and the company on the steps needed to reopen the factory.

Under the proposed consent decree, which is subject to court approval and entry, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis facility. The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase in infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. When the company decides to restart production at this facility, it must conform to the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production.

“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.”

 

After production resumes, Abbott said it will take between six-to-eight weeks before new products begin arriving in stores. The company didn’t set a timeline to restart production.

 

 

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