Abbott Says Agreement Has Been Reached to Reopen Baby Formula Plant

Baby formula maker Abbott said on Monday that it had reached an agreement with US health regulators to restart production at its largest domestic plant, though it will take some time. more than a month before any new products ship to help alleviate the national shortages parents are facing.

The White House released a statement regarding the deal, saying a proposed consent decree of a permanent ban between the Food and Drug Administration (FDA) and Abbott Nutrition, as well as three brands Abbott, was filed in the United States District Court for the Western District of Michigan. The FDA has been investigating safety concerns at Abbott’s Sturgis, Michigan, plant since earlier this year. The consent decree is the equivalent of a legally binding agreement between the FDA and the company regarding the steps needed to reopen the plant.

Under the proposed consent decree, subject to court approval and entry, Abbott agreed to take corrective actions following an FDA inspection of its Sturgis facility. The proposed consent decree obliges Abbott to take actions that are believed to ultimately lead to an increase in infant formula products, while ensuring that the company takes the most appropriate actions. established to ensure safe infant formula production on site. 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 determined, the company must notify the FDA, determine 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 some of the issues the agency has identified at its infant formula production facility in Michigan. The public should be reassured that the agency will do everything it can to continue to ensure that infant formulas and other special formulas manufactured by the company meet standards. FDA quality and safety, which American consumers expect and deserve,” said FDA Commissioner Robert M.. Califf, MD “We recognize the difficulties parents and caregivers face in procuring infant formula, and the FDA is focused on promoting the availability of a better supply of infant formula. this country’s products, including new steps related to import. We are also reviewing the supply of infant formulas developed by manufacturers across the country and around the world to determine if their distribution can be reallocated to help bringing the right product to the right place, at the right time. ”

Once production resumes, Abbott said it will take six to eight weeks before the new products start hitting stores. The company did not set a timeline for restarting production. Abbott Says Agreement Has Been Reached to Reopen Baby Formula Plant

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