FDA Launches Investigation Over Inspection Delays At Baby Formula Plant
By Bill Galluccio
May 16, 2022
The Food and Drug Administration has launched an investigation into why it took so long to begin inspecting a baby formula plant that was forced to shut down after a bacterial infection that killed two infants was linked to formula produced at the plant.
The FDA first learned about problems at the Abbott Nutrition plant in Michigan last September but failed to act. In October, the agency received a whistleblower report detailing alleged safety lapses at the plant. The FDA was slow to follow up on the report and didn't send inspectors until January.
In February, the FDA ordered the plant to close down. The plant's closure has been a driving factor in the baby shortage formula that has hit the nation. The plant was expected to be closed for several months, but FDA Commissioner Robert Califf told NBC's TODAY that he hopes the plant could begin producing baby formula within the next two weeks.
"That's entirely within the realm of possibility and, in fact, I think quite likely," he said.
Califf added that the FDA is working to alleviate the baby formula shortage and said the agency is working on a plan to allow baby formula to be imported from other countries.
"Remember that formula intended for other countries may be labeled in a language which is not the language that is needed for the instructions for mothers and other caretakers to mix up the formula," Califf said. "But I really expect by the end of the day, we'll have an announcement on that path forward."