Abbott reaches deal with FDA to reopen baby formula plant linked to shortage

Abbott Nutrition said Monday it has reached an agreement with the Food and Drug Administration to reopen its infant formula plant, paving the way for increased baby formula supply amid the ongoing shortage.

Why it matters: The U.S. has faced a massive baby formula shortage because of supply chain issues compounded by the closure of Abbott's facility in Sturgis, Michigan due to an FDA recall. Reopening the facility means more baby formula could hit store shelves soon.

Driving the news: Abbott said in a statement Monday that it can restart operating the site in two weeks. It will take another six to eight weeks before the baby formula can make its way onto shelves.

• Abbott said that an investigation between the FDA, Abbott and the Centers for Disease Control and Prevention (CDC) found "no conclusive evidence to link Abbott's formulas to these infant illnesses."

A federal court in Western Michigan approved the consent decree from the Department of Justice on Monday, which requires Abbott to seek outside expert help to keep the Michigan facility in proper condition.

Details: The FDA said Abbott agreed to make corrections to its facility following the recall that will "ultimately result in an increase of infant formula products."

• The FDA said that Abbott will have to meet FDA standards when the facility reopens.
• If any contamination is found, Abbott must tell the FDA about it and "conduct a root-cause investigation before resuming production," the FDA said.

What they're saying: "Our No. 1 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," said Robert Ford, chairman and chief executive officer of Abbott.

• "We look forward to working with the FDA to quickly and safely re-open the facility.
• "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."

The other side: "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, which American consumers have come to expect and deserve,” FDA commissioner Robert Califf said in a statement Monday.

• Attorney General Merrick Garland said that the Department of Justice "will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”

What we're watching: Califf also told the "Today" show Monday morning the agency does not expect the baby formula shortage "to last to the end of the year, by any means."

Editor's note: This story has been updated with new details throughout.