Abbott Nutrition, which shut down a plant in Michigan in February amid contamination concerns, triggering a national shortage of baby formula, said Friday that it was set to resume making its leading formula, Similac.
With production of the formula set to ramp up at the plant in Sturgis, Michigan, the company hopes to ease the shortage that left parents across the country scrambling to feed their infants.
The shortage started earlier this year after pandemic-related supply chain issues created a scarcity of ingredients for formula, and it was further exacerbated by the trouble at the Michigan plant.
Abbott CEO Robert B. Ford said that restarting Similac production was an important step in getting formula back on shelves.
“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,” Ford said in a news release. “We are committed to re-earning the trust parents and health care providers have placed in us for decades.”
It will be about six weeks before the Similac product line begins shipping, the company said, adding that restarting manufacturing at the plant after a monthslong shutdown was a “complex process” to ensure equipment was working properly.
The company warned that it was possible there would be stops and starts “from time to time.”
In February, Abbott voluntarily recalled batches of three formulas after the Food and Drug Administration received consumer complaints about a bacterium that can cause severe, life-threatening infections or inflammation of the membranes that protect the brain and spine.
Four babies who were fed formula manufactured at the Sturgis plant became sick with bacterial infections, and at least two died. Abbott has said that there is no “conclusive evidence” to link the company’s formulas to the illnesses.
Dr. Robert Califf, commissioner of the FDA, told a House panel in May that the Sturgis plant had a leaking roof, water pooling on the floor and cracks in production equipment that allowed bacteria to get in and persist.
He described the conditions as “egregiously unsanitary” and acknowledged that his agency should have acted quicker to address the problems.
Abbott entered a consent decree with the government to help provide a new series of safeguards, including hiring a qualified expert to oversee improvements at the plant and notifying the FDA if any contamination is found.
By June, Abbott resumed making EleCare, but less than two weeks after starting production, the plant was forced to close again after severe storms left parts of the facility flooded. Production of EleCare and other metabolic formulas resumed July 1, and shipments are expected to be sent in the next few weeks, the company said.
The potentially dangerous bacteria, Cronobacter sakazakii, has also been found in a couple of batches of formula since restarting production. Abbott said that the issues were identified and that the products were not affected or distributed, which “confirms our quality systems work.”
After its initial shutdown, Abbott said it increased production at other manufacturing plants in the United States and one in Ireland. The company said that this month, it would supply the United States with more than 8 million pounds of formula, which is more than what it produced last August.