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Abbott Nutrition resumed production at its baby formula factory in Sturgis, Michigan on Saturday, offering hope that a national shortage that had made parents struggling to find a livelihood for their children could be alleviated. in the coming weeks.
The company said it would resume production “after meeting the initial requirements” specified by a May consent decree with the Food and Drug Administration. The company had to get an independent expert to review operations and law enforcement, among other things.
“We understand the urgent need for formula and our top priority is to put safe, high-quality formulas in the hands of American families,” Abbott said in a statement. “We will expand production as soon as we can and meet all requirements.”
The factory closed in February after an FDA inspection detected allegedly unhealthy conditions. The factory produced most of Similac’s powder supply in the country and was the main producer of special formulas, so its closure greatly reduced supplies.
The company has previously said it will take two weeks for production to resume completely and another six to eight weeks to get the product off store shelves. The plant will prioritize the production of EleCare, a specialized formula based on amino acids for children with multiple allergies, before increasing the production of its main products. On Saturday, Abbott said he expected to launch EleCare “to consumers starting June 20 or so.”
The FDA said Saturday that it “continues to work diligently to ensure the safe resumption of infant formula production” at Abbott Nutrition’s Sturgis facility.
The temporary closure of the facility caused a dramatic disappearance of the specialized formula, causing panic among many parents who depend on products to feed their children. The crisis raised questions about the fragility of the supply chain from a critical food source. Four large companies control 90 percent of the supply of infant formulas in the United States: Abbott, Gerber, Mead Johnson, and Perrigo Nutritionals. Congress and others have harshly criticized the leadership of the FDA, Abbott executives, and even the White House for failing to avert the crisis.
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FDA Commissioner Robert M. Califf has wondered when the Sturgis facility is likely to be up and running, and told lawmakers on May 19 it could happen as soon as next week. At a hearing last week, however, he said the problems his agency encountered there were “beyond the stick” and could require major repairs.
The February inspection was done after two babies were sick and two others died after consuming contaminated formula. Abbott says there is no clear evidence that the contamination came from the factory. Inspectors found the Cronobacter sakazakii bacterium in samples they took outside the main formula production area. They found water stagnant in the ground due to a valve leak, as well as moisture and condensation in the areas of production of dry powdered infant formulas. They found cracks and pits in the dryers, as well as duct tape and debris on the floor.
Abbott says he has made a number of improvements, such as replacing a leaky roof and installing non-porous, easily cleanable and sanitary floors to eliminate the risk of stagnant water. In addition, Abbott has updated its education, training, and safety procedures for employees and visitors, as well as facility cleaning and maintenance procedures.
The reopening of the facilities will not immediately result in fully stocked grocery shelves. Even with the Fly Formula operation carrying millions of bottles from Australia, the UK and Germany, data research firm IRI reports that store inventories were still slightly worse in recent weeks compared with early May. Parents continue to report difficulties in finding the formula they need, some drive long distances and others pay a premium to buy it online.
One of the reasons the shortage persists despite efforts to increase production is that domestic producers, including Abbott, have focused on increasing the availability of specialized formulas for children with allergic and digestive disorders. Formula air transport from abroad is being largely distributed through pediatric clinics and hospitals. Califf said part of the shortage also stems from the fact that parents are accumulating the formula for fear they will run out.
The FDA has reached an agreement with the infant formula factory to resume production
Abbott said the EleCare product could hit stores in about 16 days, but that the Sturgis-made formula could take weeks to fully reach the shelves due to the time it takes for the formula to dry and be tested for safety. . The factory prepares the type of formula that is presented in powder and must be mixed with water before feeding. Batch testing adds days to the production process.
On May 16, Abbott reached an agreement with the FDA to address factory safety issues. According to the consent decree, Abbott agreed to clean and disinfect its facilities and all equipment, and to keep its new independent expert on site to ensure that the plant complies with FDA regulations. It also includes requirements to test products, as well as stop production and notify the FDA immediately if contamination is detected.