The baby formula manufacturer at the heart of a nationwide recall says it has reached an agreement with the FDA on steps necessary to resume production at its shuttered plant.
The baby formula manufacturer at the heart of a nationwide formula recall said Monday that it has reached an agreement with the US Food and Drug Administration to enter into a consent decree, a legally binding agreement that would require the company to take certain steps in response to violations found at its Sturgis, Michigan, facility.
If a court approves the agreement, the company says, it could restart the site within two weeks. It would first resume the production of its specialty metabolic formulas EleCare and Alimentum, followed by Similac and other formulas.After Abbott restarts the site, it will take six to eight weeks for the products to reach store shelves, it said.The Justice Department said Monday that it had filed the proposed consent decree in federal court.
Genetic samples from sick babies also did not match each other, suggesting that there was no link between their cases, Abbott said in its news release. Cronobacter bacteria is commonly found in the environment. Additionally, Abbott said, no baby formula distributed to consumers tested positive for Cronobacter or Salmonella. "Our safety and quality processes meet even the toughest scrutiny and we're committed to continuously improving our processes and protocols," Ford said.
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