FDA Chief Califf: Agency Likely to OK Abbott’s Baby Formula Plant Reopening

Food and Drug Administration Commissioner Dr. Robert Califf said on Monday the agency is likely to approve the reopening of Abbott Laboratory’s baby formula manufacturing facility in Sturgis, Michigan, in two weeks after ensuring that the product is safe and any problems have been rectified.

“We have an obligation to watch to make sure the problems have been rectified and the formula will be safe, remembering that normal formula has over 30 constituents that must be there as a substitute for breast milk,” Califf told NBC “Today” anchor Savannah Guthrie. “Very soon, you should hear an announcement about moving forward, and of course, Abbott is responsible with the timeline but I’m very comfortable with what they said about two weeks … [it’s] entirely within the realm of possibility, and I think quite likely.”

Abbott closed its Sturgis facility earlier this year after complaints surfaced of infants becoming ill with bacterial contamination. The company says its plants are “not likely the source of infection,” after the FDA cited five separate cases of illness in babies that were given the company’s formula, with two of the babies dying.

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