Baby Formula Factory

An Abbott Laboratories manufacturing plant is shown in Sturgis, Mich., on Sept. 23, 2010. Abbott Nutrition has restarted production at the Michigan baby formula factory that’s been closed for months due to contamination, the company said. Brandon Watson/Sturgis Journal via AP, File

Abbott Nutrition is resuming production at its shuttered Sturgis, Mich., baby formula factory on Saturday, offering hope that a nationwide shortage that had left parents scrambling to find sustenance for their children may ease in the coming weeks.

The company said it was resuming production “after meeting initial requirements” that were specified by a May consent decree with the Food and Drug Administration.

The factory was closed five months ago 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 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 crisis sparked panic for many parents who rely on formula to feed their children and 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 February inspection took place after two infants were sickened and another two infants died after consuming contaminated formula. Abbott says there isn’t clear evidence the contamination came from the factory. Inspectors found Cronobacter sakazakii bacteria on 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.

Reopening of the facility 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 reports 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 availability of specialty formulas for children with allergic and digestive disorders. Airlifts of formula from abroad are largely being distributed via pediatrician 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 around 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 an independent expert on-site to make sure the plant is in compliance with FDA rules. It also includes requirements for testing products, as well as ceasing production and immediately notifying the FDA if contamination is detected.

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