HHS watchdog to probe FDA recall, inspection of shut baby formula plant

The federal government will review whether the Food and Drug Administration properly inspected the Abbott Laboratories baby formula plant in Michigan whose closure over unsanitary conditions caused a nationwide shortage that left the Biden administration unprepared.

The Department of Health and Human Services inspector general’s office will conduct the review that is expected to conclude sometime next year, the agency said in a statement Thursday. 

“​W​e will review FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott’s initiation of the infant formula recall​,” HHS said.

The recall and shutdown of the Sturgis, Mich. facility in February sparked a shortage that left store shelves barren and prompted desperate parents to search far and wide for bottles of the formula needed to feed their children. 

On Wednesday, ​President Biden admitted following a meeting with baby formula manufacturers that he was unaware of the crisis until April. ​

“The question you all ask on every single thing is, ‘Why didn’t you act sooner?’ Well, I don’t think anyone anticipated the impact of the shutdown of one facility — the Abbott facility,” Biden told reporters​.

Abbott is one of four companies that supply around 90% of the nation’s baby formula.​

Biden was asked at the Wednesday event whether the FDA should have been more aware of the consequences of shutting the Abbott plant.​

“Here’s the deal: I became aware of this problem sometime after April — in early April about how intense it was. And so we did everything in our power from that point on and that’s all I can tell you right now,” he replied. 

The Biden administration has been playing catch-up for weeks to try to ease the shortage. 

The president last month invoked the Defense Production Act to ensure materials reach baby formula manufacturers.

The administration has also authorized shipments of formula from Europe. 

Abbott’s Michigan plant is expected to reopen in the next couple of weeks.