Abbott agrees to consent decree with FDA, could restart plant within 2 weeks, pending court approval

If a court approves the deal, the company said, it could restart the site within two weeks. It would first resume 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 products to hit store shelves, he said.

The Justice Department said Monday it had filed the proposed consent decree in federal court.

Abbott said it submitted corrective action to the FDA on April 8. But even before that official response, she had been working on improvements, including reviewing and updating education, training and safety procedures for employees and visitors and updating water protocols. , cleaning and maintenance. establishment procedures.

Additionally, Abbott said it immediately took steps to address the issues raised by the FDA at the end of its inspection.

“Our number one priority is to provide infants and families with the high-quality formulas they need, and this is a major step towards reopening our Sturgis facility so that we can alleviate the shortage of formulas at the nationwide. We look forward to working with the FDA to quickly and safely reopen the facility,” Abbott Chairman and Chief Executive Officer Robert B. Ford said in a press release. Millions of parents and caregivers depend on us, and we are deeply sorry that our voluntary recall has exacerbated the nationwide formula shortage. We will work hard to regain the trust that moms, dads and caregivers have placed in our formulas for over 50 years.”

During an inspection that spanned several dates in January, February and March, FDA investigators found Cronobacter sakazakii bacteria in several areas inside the plant.

Additionally, the FDA’s review of company records revealed that Abbott detected Cronobacter bacteria in batches of finished formulas produced in 2019 and 2020.

In preliminary findings, the FDA reported that Abbott had not established a process control system covering all processing steps to prevent contamination of preparations by microorganisms and that all surfaces that touched preparations for infants were cared for to avoid contamination.

Ultimately, however, tests by the FDA and the US Centers for Disease Control and Prevention revealed that the genetic sequences of Cronobacter samples from inside the plant did not match any of the bacteria isolated from the plants. sick children or formula inside their homes. , so no link was found with the Sturgis installation.

Genetic samples from sick babies also did not match, suggesting there was no link between their cases, Abbott said in his press release. Cronobacter bacteria are commonly found in the environment.

Additionally, Abbott said, no infant formula distributed to consumers has tested positive for Cronobacter or Salmonella.

“Our safety and quality processes meet the most rigorous reviews and we are committed to continually improving our processes and protocols,” Ford said. “Nutrition is fundamental to Abbott and to our goal of improving the lives of more than 3 billion people by the end of the decade. We intend to set the standard for the industry, elevating the bar in terms of safety and quality.”

CNN’s Laura Smitherman contributed to this report.

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