Abbott, Manufacturer Of Infant Milk Formula, Reaches Agreement With The FDA

US suffers from baby formula shortage, knows why 3:02

(WABNEWS) — The infant formula maker at the center of a nationwide recall said Monday it has reached a settlement with the US Food and Drug Administration. acronym) to enter into a consent decree, a legally binding agreement that would require the company to take certain actions in response to violations found at its facility in Sturgis, Michigan.

If a court approves the settlement, the company says that it could restart production at the facility within two weeks. It would resume production of its specialty metabolic formulas EleCare and Alimentum first, followed by Similac and other formulas.


Once Abbott gets the facility back up and running, it will take six to eight weeks for the products to reach stores, he said.

The Justice Department He said Monday that he had submitted the proposed consent decree to federal court.

Abbott said it filed a corrective action with the FDA on April 8. But even before this formal response, he had been working on improvements, including reviewing and updating education, training, and safety procedures for employees and visitors and updating protocols regarding water, cleaning, and sanitation. facility maintenance procedures.

Additionally, Abbott said it took immediate steps to address the points the FDA raised at the conclusion of its inspection.

“Our number one priority is providing babies and families with the high-quality formula they need, and this is an important step toward reopening our Sturgis facility so we can address formula shortages across the country. We look forward to working with the FDA to quickly and safely reopen facilities,” Abbott Chairman and CEO Robert B. Ford said in a news release. “We know that millions of parents and caregivers depend on us and we deeply regret that our voluntary recall has exacerbated formula shortages across the country. We will work hard to earn back the trust that mothers, fathers and caregivers have placed in in our formulas for more than 50 years.

During an inspection that spanned multiple dates in January, February, and March, FDA investigators they found the bacterium Cronobacter sakazakii in various areas within the plant.

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

In preliminary findings, the FDA reported that Abbott failed to establish a system of process controls covering all stages of processing to prevent contamination of formula with microorganisms and that all surfaces that touched infant formula followed a protocol to prevent contamination of formula. contamination.

In the end, however, tests by the FDA and the US Centers for Disease Control and Prevention (CDC) found that the genetic sequences of Cronobacter samples from inside the plant did not match any of the bacteria isolated from sick children or formula milk in their homes, so no relationship to the Sturgis plant was found.

The genetic samples of the sick babies also did not match each other, suggesting there was no relationship between their cases, Abbott said in his news release. Cronobacter bacteria are commonly found in the environment.

Additionally, Abbott said that none of the infant formula distributed to consumers tested positive for Cronobacter or Salmonella.

“Our safety and quality processes are up to the strictest scrutiny and we are committed to continually improving our processes and protocols,” Ford said. “Nutrition is central 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, raising the bar on both safety and quality. “

— WABNEWS’s Laura Smitherman contributed to this report.



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