Abbott Nutrition is resuming production of Similac, its leading baby formula, at a Michigan plant that was shut down earlier in 2022 because of contamination concerns.
The company closed the plant in February, which triggered a national shortage of baby formula amid pandemic-related supply chain issues that created a lack of formula ingredients.
“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,” Robert Ford, chairman and CEO of Abbott, said in a statement on Aug. 26.
“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,” he said. “We are committed to re-earning the trust parents and health care providers have placed in us for decades.”
Abbott estimated that it will take about 6 weeks for Similac products to ship to stores. Production has restarted, which will be followed by “enhanced” testing before and after the formula is made.
In February, Abbott voluntarily recalled batches of three formulas after the Food and Drug Administration received consumer complaints about infants becoming sick. Four babies who consumed formulas from the Michigan plant got bacterial infections, and at least two babies died.
The illnesses were linked to Cronobacter sakazakii – bacteria that can lead to life-threatening infections and inflammation of the brain and spine.
After investigations at the plant, Abbott said there is no conclusive evidence to link the formula to the illnesses. No samples of the recalled product tested positive for the bacteria, and in all four cases, unopened containers of formula in the infants’ homes tested negative for the bacteria.
At the same time, FDA officials said in May that the Michigan plant had a leaking roof, water pooling on the floor, and cracks in production equipment that could allow bacteria to grow, according to The New York Times.
Abbott agreed with the federal government to create new safeguards, such as hiring a qualified expert to oversee improvements at the plant and notify the FDA if any issues were identified, the newspaper reported.
On July 1, the company restarted production of EleCare, a specialty formula, and later resumed production of some metabolic formulas. These products will begin to ship in coming weeks, the company said.
Since July, C. sakazakii has been found in a couple of batches of formula.
“In those cases, we found the issue, addressed it and no affected product has been or will be distributed,” Abbott said in the statement. “This confirms our quality systems work.”
In August, Abbott will supply the United States with more than 8 million pounds of infant formula, which is higher than the levels in August 2021, the company said. To ensure that people in the federal Special Supplemental Nutrition Program for Women, Infants and Children have access to formula, the company is extending rebates until the end of October.
“Restarting a large manufacturing facility after a several-month shutdown is a complex process, and it takes time to ensure that equipment, processes and production are functioning smoothly and sustainably,” the company said in the statement. “There have been – and likely will be – stops and starts from time to time. We’ve experienced events like severe weather, we’ve had to make mechanical adjustments, and we’ve had to discard some early production batches that didn’t meet our standards.”
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