U.S – Abbott Nutrition has resumed operations at its Sturgis, Michigan, US, plant just a week after complying with the initial requirements agreed to with the US Food and Drug Administration (FDA).
This will ease the nationwide shortage of baby formula, which has caused havoc across the country over the last few weeks.
Abbott Nutrition says it will restart the production of EleCare, a formula for children with digestive issues with the aim of releasing it later this month.
The company has been at the center of the infant formula challenges since the Michigan plant closed down in February amid contamination concerns.
FDA investigations began after four infants were hospitalized with bacterial infections from drinking Abbott’s powdered formula. Two of the babies died.
Abbott now stresses that it’s focused on earning trust and meeting guidelines to produce other formulas, as reported by Food Ingredients First.
It’s also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as possible.
“We understand the urgent need for formula, and our top priority is getting high-quality, safe formula into the hands of families across America.
“We will ramp production as quickly as we can while meeting all requirements. We’re committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years,” says a company statement.
Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law.
It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.
In response to the formulas shortage, the FDA released an update on additional steps it has taken that will lead to more infant formula available in the US under the agency’s recent increased flexibilities.
It has greenlighted the importation of about 1.3 million cans of Nestlé (Mexico) Gerber Good Start Gentle.
“The FDA is exercising enforcement discretion for the importation of the infant formula products listed following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history,” said FDA.