From CNBC.com…
Abbott reached an agreement with the Food and Drug Administration on Monday to reopen the company’s manufacturing plant in Michigan to help ease a nationwide shortage of baby formula, after the facility was closed due to bacterial contamination.
FDA Commissioner Robert Califf said Abbott, under the conditions of the agreement, has agreed to address insanitary conditions that led to the contamination and plant closure.
“The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards,” Califf said in a statement.
The agreement between Abbott and the FDA, called a consent decree, is subject to approval by the U.S. District Court for the Western District of Michigan. Abbott can restart the Sturgis, Michigan, plant within two weeks subject to court approval, the company said. However, it said it would take six to eight weeks from the start of production for formula to arrive on store shelves.
Mothers are struggling to find formula for their infants with shelves empty in many stores across the U.S. More than 40% of baby formula was out of stock in the U.S. during the week ended May 8, according to Datasembly, a retail data tracker. However, the FDA said Monday that nearly 80% of baby formula was in stock, citing data from Information Resources, another retail data company.
