FDA took months to react to complaint about Abbott infant formula factory, audit finds

The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide shortage of infant formula, a new audit shows. But one of several staff members charged with managing the FDA inbox at the time “inadvertently archived” the email in February 2021, and it wasn’t found until a reporter requested it in June 2022. The FDA took some actions and did follow-up inspections but “more could have been done leading up to the Abbott powdered infant formula recall,” the auditors wrote. The FDA established a “critical foods investigator cadre, which will solely focus on the inspection and oversight of the infant formula industry,” the spokesperson said. Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, said he agreed with the report’s recommendations, which include that Congress should give the FDA the power to require manufacturers report any test showing infant formula contamination, even if the product doesn’t leave the factory.