By Ahmed Aboulenein and Susan Heavey
WASHINGTON (Reuters) – Abbott Laboratories and the U.S. Food and Drug Administration are on track to reopen the company’s Sturgis, Michigan, baby formula manufacturing plant within one or two weeks, FDA Commissioner Robert Califf said on Thursday.
Abbott, the biggest U.S. supplier of powder infant formula including Similac, on Monday agreed with the FDA on steps needed to resume production at the manufacturing plant.
“I think we are on track to get it open within the next week to two weeks, most likely at the outer bound two weeks,” Califf told lawmakers at a U.S. House of Representatives Appropriations Subcommittee hearing.
The company had initiated a recall of its infant formula products and closed the plant in February after reports of serious bacterial infections in four infants, worsening a shortage among multiple manufacturers that began with pandemic supply chain issues.
The FDA cannot conclude whether cases of ill babies are directly related to the Abbott plant until its investigation is concluded, Califf said.
(Reporting by Ahmed Aboulenein and Susan Heavey; Editing by Franklin Paul and Chizu Nomiyama)