Abbott Reaches Deal with FDA to Resume Infant Formula Production at Sturgis Plant

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Abbott Infant Formula Products

Abbott (NYSE: ABT) reached an agreement with the U.S. Food and Drug Administration (FDA) to resume production of infant formula products at its manufacturing facility in Sturgis, Michigan.

In February, Abbott Nutrition voluntarily recalled some of its baby formula products including Similac, Alimentum, and Elecare. The company also stopped its production at the Sturgis plant. Its decision was prompted by concerns that its powdered baby formula products produced at the plant were contaminated with Cronobacter sakazakii or Salmonella Newport, a germ that can cause a dangerous blood infection (sepsis) or swelling of the linings surrounding the brain and spinal cord (meningitis). 

The FDA and the Centers for Disease and Control Prevention (CDC) investigated four consumer complaints related to Cronobacter sakazakii in infants who consumed powdered infant formula manufactured at the company Sturgis facility.

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The recall and closure of its Michigan manufacturing facility resulted in a supply shortage of infant formula products. Restarting its production at the facility could help ease the supply shortage across the United States.

On Monday, Abbott said its agreement called Consent Decree stipulates the requirements it must follow to resume production and maintain its Sturgis facility. Once the FDA confirms that the company met the initial requirements for start-up, it could restart the facility within two weeks.

In a statement, Abbott Chairman and CEO Robert Ford said, “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.'”

“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,” he added.

FDA and CDC investigation findings

The FDA and CDC conducted a thorough investigation into the consumer complaints related to Abbott’s baby formula products. The agencies did not find conclusive evidence linking the company’s products to the infants’ illnesses.

The FDA and CDC found that the company conducts microbiological testing before distributing its infant formula products to consumers. None of its products tested positive for Cronobacter sakazakii or Salmonella. 

During the FDA inspection at the Sturgis facility, the agency and the company tested all retained products. The test results came back negative for Cronobacter sakazakii or Salmonella. 

The environmental testing showed that Cronobacter sakazakii were present in non-product contact areas of the facility and has not been linked to any infant illnesses.

The genetic sequencing on the two available samples from sick infants did not match the strains of Cronobacter sakazakii found at the Sturgis plant. Samples from the sick infants did not match each other, which means the two cases have no connection.

“Our safety and quality processes meet even the toughest scrutiny and we’re committed to continuously improving our processes and protocols,” said Mr. Ford.

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