Abbott Nutrition is restarting infant formula production at its Sturgis plant, Michigan, US, after halting Similac production in February. The company estimates products will hit the shelves in six weeks after production restarts.
“We know that the nationwide infant formula shortage has been difficult for the families we serve, and while restarting Similac production in Michigan is an important milestone, we won’t rest until this product is back on shelves,” says Robert B. Ford, chairman and CEO at Abbott Nutrition.
“Making infant formula is a responsibility we take very seriously, and parents can feel confident in the quality and safety of Similac and other Abbott formulas. We are committed to re-earning the trust parents and healthcare providers have placed in us for decades.”
Cronobacter guiding approach
The company was investigated earlier this year for bacteria in the plant. The US Food and Drug Administration (FDA) revealed the presence of Cronobacter sakazakii in the plant, causing hospitalization and fatal cases in infants.
Four cases of hospitalization were reported, where two infants died. A few months later, in June, another fatal case was reported by parents suspecting the bacteria to be the cause of death.
In June, the plant suffered severe extreme weather that caused flooding, forcing Abbott to shut down for the second time this year, severing the supply during the ongoing nationwide formula shortage crisis. The company voluntarily recalled the Similac, Alimentum and EleCare powdered formulas. In July, the company restarted the production of specialty formulas for Elecare.
“We have a zero-tolerance policy for Cronobacter or any pathogen in our plants. Cronobacter is naturally and commonly found in the environment, and our quality systems are designed to find it and destroy it when it’s present, as it sometimes is with all manufacturers,” Abbott underscores.
“That is why we test for it regularly and take steps to eliminate it if and when we find it, is why we took the steps we did in Sturgis in February and is what guides our approach today.”
Bacteria won’t budge
The company highlights the process of restarting production after being shut down for several months is “complex”. Ensuring that equipment, processes and production operate smoothly require effort in tackling unexpected happenings such as extreme weather and preparing for future challenges, Abbott notes.
Despite the controversy, Abbott restarted production for its EleCare product on July 1 and later moved on to some metabolic formulas. Since then, the company notes a few batches containing the Cronobacter have been detected.
“In those cases, we found the issue, addressed it, and no affected product has been or will be distributed. This confirms our quality systems work.”
“We make our products as if they were for our own families. It’s important to us at Abbott that the public knows that the quality and safety of our products is our first priority, that we conduct microbiological testing throughout the manufacturing process, and that we would never release products that don’t meet our quality and safety standards,” Abbott notes.
The company underscores that it will have supplied the US with 8 million pounds of infant formula in August, “which is above what we produced in August 2021.”
Even though Abbott voluntarily recalled its products, the FDA allowed sales of the three formula types to continue to tackle the supply shortage.
