Abbott (NYSE:ABT) announced an agreement with U.S. Food and Drug Administration (FDA) on Monday regarding the plans necessary to reopen its Sturgis, Mich., infant formula plant.
The announcement of the so-called consent decree between the agency and the company on the manufacturing facility comes amid a nationwide shortage of baby formula. The agreement is subject to court approval, Abbott (ABT) said.
"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” Chief Executive Robert B. Ford remarked.
“We look forward to working with the FDA to quickly and safely re-open the facility," he added.
Abbott (ABT) said there would be yet-to-be-quantified one-off charges related to the implementation of the consent decree. However, the company reiterated its previously issued earnings guidance.
Abbott (ABT) was forced to halt operations of the plant early this year with a voluntary recall of certain baby formulas manufactured at facility following several complaints about bacterial infections after consumption.
However, an investigation by the FDA, the Centers for Disease Control and Prevention (CDC) found no evidence to link Abbott's (ABT) formulas to these infant illnesses, the company added. The CDC concluded its investigation last week, according to a notice from the federal agency.