FDA, Abbott reach deal to reopen shuttered infant formula plant


Abbott Nutrition, the infant formula manufacturer at the center of nationwide shortages, announced on Monday it had reached a deal with the FDA on steps for the company to reopen a currently shuttered processing plant.

FDA Commissioner Robert Califf said Abbott, under the conditions of the agreement, will correct insanitary conditions that led to the contamination and plant closure.

Abbott on Monday entered a consent decree with the FDA paving the way for reopening the plant. The agreement, subject to court approval, lays out the steps needed to resume production at the facility.

“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,” said Robert B. Ford, chairman and chief executive officer of Abbott. “We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage.”

“I am very comfortable with what they said about two weeks,” Dr. Califf told host Savannah Guthrie.

“That’s entirely within the realm of possibility and, in fact, I think quite likely,” he added regarding Abbott’s proposed timeline.

From the time Abbott restarts the site, it will take six to eight weeks before product hits store shelves.

Califf said the FDA would investigate the plant to ensure that it is free of contamination and that formula produced at the facility contains all of the ingredients that make it a suitable substitute for breast milk.

He also dismissed claims that the national baby formula shortage, which has worsened in past weeks, could last through the end of the year.

“We don’t expect it to last until the end of the year by any means. We’re taking a number of measures including getting all the manufacturers to step up,” he said.

He added that the FDA would release more details on the “path forward” by the end of the day Monday.

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