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Abbott Nutrition resumed production at its closed baby formula factory in Sturgis, Michigan, on Saturday, offering hope that the nationwide shortage that has forced parents struggling to make a living for their children could ease in the coming weeks.
The company said it was resuming production “after meeting the initial requirements” set by a May decree agreeing with the Food and Drug Administration. The company had to get an independent expert to review operations and compliance with the law, among other things.
“We understand the urgent need for formula, and our top priority is to get a high-quality, safe formula in the hands of families across America,” Abbott said in a statement. “We will increase production as quickly as possible, while meeting all requirements.”
The factory closed in February after an FDA inspection identified alleged unsanitary conditions. The factory produced most of Similac’s powder supplies in the country and was the main producer of special formulas, so its closure severely limited supplies.
The company said earlier that it would take two weeks to resume production completely and another six to eight weeks to put the product on store shelves. The plant will give priority to the production of EleCare, a special formula based on amino acids for children with multiple allergies, before increasing the production of its mass products. On Saturday, Abbott said it expects to launch EleCare “for consumers starting on or around June 20.”
The FDA said Saturday that it “continues to work hard to ensure the safe resumption of infant food production” at the Abbott Nutrition facility in Sturgis.
The temporary closure of the facility has led to the dramatic disappearance of the specialized formula, causing panic among many parents who rely on products to feed their children. The crisis has raised questions about the fragility of the supply chain for a critical food source. Four major companies control 90 percent of infant food supply in the United States: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Congress and others have strongly criticized FDA officials, Abbott leaders and even the White House for failing to prevent the crisis.
Biden says he heard late about the shortage of formula
FDA Commissioner Robert M. Calif wondered when the Sturgess facility was likely to become operational, telling lawmakers on May 19 that it could happen as early as next week. However, in a hearing last week, he said the problems his agency had identified were “beyond pallor” and could require more substantial rectification.
The inspection took place in February after two babies fell ill and two others died after consuming contaminated formula. Abbott says there is no clear evidence that the pollution came from the factory. Inspectors found Cronobacter sakazakii bacteria in samples they took outside the basic formula production area. They found stagnant water on the floor due to leaking valves, as well as moisture and condensation in baby milk powder production areas. They found cracks and pits in the dryers, as well as duct tape and debris on the floor.
Abbott says it has made a number of improvements, including replacing a leaking roof and installing non-porous, easy-to-clean and sanitary floors to eliminate the risk of stagnant water. In addition, Abbott updated its training, training and safety procedures for staff and visitors, as well as cleaning and maintenance procedures at the facility.
Reopening the facility will not immediately result in fully loaded food shelves. Even after Operation Fly Formula brought in millions of bottles from Australia, the United Kingdom and Germany, data research firm IRI said store inventories were still slightly worse in recent weeks than in early May. Parents continue to report difficulties in finding the formula they need, with some driving long distances and others paying a premium to buy it online.
One reason to maintain the shortage despite efforts to increase production is that local manufacturers, including Abbott, have focused on increasing the availability of special formulas for children with allergic and digestive disorders. Air transport of adapted milk from abroad is largely distributed through pediatric offices and hospitals. Caliph said part of the shortage stems from parents accumulating formula for fear of running out.
The FDA has reached an agreement with the baby formula factory to resume production
Abbott said the EleCare product could reach stores in about 16 days, but it could take weeks for the Sturgis-made formula to fully reach the shelves due to the time it takes to dry and test the safety of the formula. The factory produces adapted milk, which is available in powder form and must be mixed with water before meals. Batch testing adds days to the production process.
On May 16, Abbott reached an agreement with the FDA to address factory safety issues. Under the Consent Decree, Abbott agreed to clean and disinfect its facility and all equipment and to retain its new independent expert on site to ensure that the plant complies with FDA regulations. It also includes requirements for product testing, as well as cessation of production and immediate notification to the FDA if contamination is detected.
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