“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America,” Abbott said in a statement. “We will ramp production as quickly as we can while meeting all requirements.”
The factory was closed earlier this year after an FDA inspection turned up allegedly unsanitary conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so its closure severely curtailed supplies.
The company has said previously that it will take two weeks for production to fully resume and another six to eight weeks to get the product on store shelves. The plant will prioritize the production of EleCare, a specialty amino acid-based formula for children with multiple allergies, before it ramps up production of its mainstream products. On Saturday, Abbott said it expected to release EleCare “to consumers beginning on or about June 20.”
The FDA on Saturday said that it “is continuing to work diligently to ensure the safe resumption of production of infant formula” at Abbott Nutrition’s Sturgis facility.
The temporary closure of the facility led to a dramatic disappearance of specialty formula, sparking panic among many parents who rely on the products to feed their children. The crisis raised questions about the fragility of the supply chain for a critical food source. Four major companies control 90 percent of the infant formula supply in the United States: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Congress and others have heavily criticized FDA leadership, Abbott executives and even the White House for failing to head off the crisis.
FDA Commissioner Robert M. Califf has waffled about when the Sturgis facility would probably be up and running, telling lawmakers on May 19 that it might happen as soon as that following week. In a hearing last week, however, he said problems his agency found there were “beyond the pale” and might require more significant remediation.
The inspection in February took place after two infants were sickened and two others died after consuming contaminated formula, but the source of the contamination is unclear.
Other things might have contaminated the formula before it was consumed and after the product left the manufacturing facility. For instance, in one case bacteria was found on a bottle of distilled water at the infant family’s home.
Abbott says there isn’t clear evidence that the contamination came from the factory. Inspectors found Cronobacter sakazakii bacteria on environmental samples they took outside the main formula production area. They found standing water on the floor because of a leak from valves, as well as moisture and condensation in dry powdered infant formula production areas. They found cracks and pits in dryers as well as duct tape and debris on the floor.
Abbott says it has made a number of upgrades, including replacing a leaking roof and installing nonporous, easily cleanable and sanitary floors to remove the risk of standing water. In addition, Abbott has updated its education, training and safety procedures for employees and visitors, as well as its cleaning and maintenance procedures at the facility.
The facility’s reopening will not immediately lead to fully stocked grocery shelves. Even with Operation Fly Formula bringing in millions of bottles from Australia, the United Kingdom and Germany, data research firm IRI reported that store inventories were still slightly worse in recent weeks when compared with the beginning of May. Parents continue to report difficulty finding the formula they need, with some driving long distances and others paying a premium to buy it online.
One reason shortages persist despite efforts to ramp up production is that domestic producers, including Abbott, have focused on increasing the availability of specialty formulas for children with allergic and digestive disorders. Airlifts of formula from abroad are largely being distributed via pediatricians offices and hospitals. Califf has said some of the shortage also stems from parents hoarding formula out of fear they will run out.
Abbott said the EleCare product could reach stores in about 16 days, but it could take weeks for the formula made in Sturgis to fully reach shelves because of the time required for the formula to be dried and safety-tested. The factory makes the type of formula that comes in powdered form and must be mixed with water before feeding. Testing of batches adds days to the production process.
On May 16, Abbott came to an agreement with the FDA to fix safety issues at the factory. Under the consent decree, Abbott agreed to clean and sanitize its facility and all equipment, and to keep its new independent expert on-site to make sure the plant is in compliance with FDA rules. The consent decree also includes requirements for testing products, as well as ceasing production and immediately notifying the FDA if contamination is detected.