“We understand the urgent need for formula, and our top priority is to have a safe, high-quality formula in the hands of families across America,” Abbott said in a statement. “We want to increase production as fast as we can while meeting all requirements.”
The factory was closed earlier this year after an FDA inspection revealed allegedly unhygienic conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so the closure greatly reduced supplies.
Fraud, long journeys, empty shelves: What parents can tolerate in the hunt for baby replacements
The company has previously said that it will take two weeks before production starts again and another six to eight weeks to get the product on store shelves. The factory will prioritize the production of EleCare, a specialty amino acid-based formula for children with multiple allergies, before increasing the production of its regular products. On Saturday, Abbott said they expect to release EleCare “to consumers beginning on or around June 20.”
The FDA said Saturday that it “continues to work diligently to ensure the safe resumption of breast milk substitute production” at Abbott Nutrition’s Sturgis plant.
The temporary closure of the facility led to a dramatic disappearance of the specialty formula, triggering panic among many parents who depend 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 in the United States: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Congress and others have strongly criticized the FDA leadership, Abbott leaders and even the White House for not averting the crisis.
Biden says that he heard late about the lack of infant formula
FDA Commissioner Robert M. Califf has wondered when the Sturgis plant will probably be up and running, and told lawmakers on May 19 that it could happen as soon as next week. However, in a hearing last week, he said that problems that his agency found there were “outside the pale” and may require more significant remediation.
The inspection in February took place after two infants became ill and two others died after ingesting a contaminated formula, but the source of the contamination is unclear.
Other things may have contaminated the formula before it was consumed and after the product left the production plant. For example, in one case, bacteria were found in a bottle of distilled water at the home of the infant family.
Abbott says there is no clear evidence that the pollution 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 due to a leak from valves, as well as moisture and condensation in dry powdered infant formulas. They found cracks and pits in the dryers as well as duct tape and debris on the floor.
Abbott says they have made a number of upgrades, including replacing a leaking roof and installing non-porous, easy-to-clean and sanitary floors to eliminate the risk of standing water. In addition, Abbott has updated its education, training and safety procedures for employees and visitors, as well as the procedures for cleaning and maintaining the facility.
The reopening of the facility will not immediately lead to full grocery shelves. Even with Operation Fly Formula bringing in millions of bottles from Australia, the UK and Germany, computer research firm IRI reported that store inventories were still slightly worse in recent weeks compared to early May. Parents continue to report difficulty finding the formula they need, some driving long distances and others paying a premium to buy it online.
One reason the shortage persists despite attempts to increase production is that domestic producers, including Abbott, have focused on increasing the availability of special formulas for children with allergic and digestive diseases. Air lifts with a formula from abroad are largely distributed via pediatrician offices and hospitals. Califf has said that some of the deficiency also stems from parents who hoard formula for fear that they will run out.
The FDA agrees with the baby replacement factory to resume production
Abbott said the EleCare product could reach stores in about 16 days, but it could take weeks before the formula made in Sturgis reaches the shelves due to the time it takes before the formula is dried and safety tested. The factory makes the type of formula that comes in powder form and must be mixed with water before feeding. Batch testing adds days to the production process.
On May 16, Abbott agreed with the FDA to fix safety issues at the factory. According to the consent decree, Abbott agreed to clean and sanitize the plant and all equipment, and to keep the new independent expert on site to ensure that the plant complies with FDA regulations. The Decree of Consent also includes requirements for testing products, as well as stopping production and immediately notifying the FDA if contamination is detected.